Susan Haigney

Woman holding multiple GLP-1 injection pens, weight loss and diabetes treatment concept | Image Credit: ©Kateryna -stock.adobe.com

Novo Nordisk announced on July 21, 2026 that it has filed a lawsuit against Eli Lilly and Company and Lilly USA, LLC in the US District Court for the District of New Jersey, alleging that Lilly's nationwide direct-to-consumer advertising for Zepbound (tirzepatide) and Mounjaro (tirzepatide) violates federal and state false-advertising and unfair-competition statutes, including the 

 The complaint contends that Lilly's campaigns mislead people living with obesity and type 2 diabetes by leaving out information about the most effective injectable doses of 

 and Ozempic (semaglutide) currently on the market.

The suit follows a formal cease-and-desist letter Novo Nordisk sent to Lilly over the advertisements. According to the complaint, Lilly declined to pull the ads down or issue a meaningful correction in response.

Novo Nordisk Inc., headquartered in Plainsboro, New Jersey, is the US affiliate of Novo Nordisk, the Denmark-based drugmaker. The US business has operated for roughly 40 years and employs about 10,000 people across more than 10 manufacturing, research and development, and corporate sites in 7 states and Washington, D.C. Globally, the company employs approximately 67,900 people and markets products in around 170 countries. 

, the defendant, is headquartered in Indianapolis.

Zepbound-Wegovy Comparison Omits Newest FDA-Approved Dose

According to the complaint, 1 campaign compares the maximum tolerated dose of 

 (10 mg/15 mg) against a lower dose range of Wegovy, 1.7 mg/2.4 mg. The ads do not reference the 7.2 mg dose of injectable Wegovy, which the FDA approved in March 2026.

That approval was supported by the STEP UP trial, a 72-week study of 1407 adults with obesity (BMI of 30 kg/m2 or greater) without diabetes. Participants taking Wegovy 7.2 mg lost an average of 18.8% of body weight (about 47 pounds) compared with 3.9% (about 10 pounds) among those on placebo. The most commonly reported adverse reactions were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss, and flatulence.

Novo Nordisk's complaint also notes that no head-to-head clinical trial has directly compared the highest doses of Zepbound and Wegovy, which the company argues makes the comparative claims especially misleading. The campaign has run during widely viewed sporting broadcasts and on TikTok and Facebook, according to the company.

Mounjaro Ads Skip Newer Ozempic Maintenance Dose

A second campaign compares Mounjaro at its highest available dose, 15 mg, against injectable Ozempic at 1 mg. The complaint states that the FDA approved a higher, 2 mg maintenance dose of Ozempic more than 4 years ago, a dose the ads do not mention.

“As new and more effective treatment options become available, people deserve accurate information that reflects the latest scientific evidence and helps them make informed care decisions,” said 

, senior vice president and Group General Counsel, Novo Nordisk, said in a press release.

 “Healthcare companies have a responsibility to keep their public claims accurate and current—ineffective, fine-print disclaimers do not fix the misleading impression created by major national campaigns.”

Novo Nordisk is asking the court for a permanent injunction requiring Lilly to remove the disputed advertising from all platforms and to run a corrective campaign. The company has told Lilly that, absent a voluntary withdrawal of the ads, it intends to file a motion in the coming days seeking a preliminary injunction, along with evidence it says shows consumers have been confused and misled, to block the ads immediately.

Is There a Potential Impact on Drug Manufacturing?

The lawsuit is a private Lanham Act and state unfair-competition action, not an FDA enforcement proceeding, and its outcome (an injunction, corrective advertising, damages) would affect Lilly's marketing materials, not the FDA-approved product labels for Zepbound or Mounjaro. The complaint is about promotional omissions, not about what's approved. The doses at issue on both sides, Wegovy 7.2 mg and Ozempic 2 mg, are already FDA-approved and already reflected in each drug's label.

The lawsuit does reflect the complexity of the GLP-1 market, and there have been regulatory actions involving promotional materials. The FDA's Office of Prescription Drug Promotion sent warning letters to Lilly, Novo Nordisk, and Hims & Hers over misleading GLP-1 promotion, part of a broader White House-directed crackdown that has included roughly 30 letters to telehealth and compounding operators and reported plans for dozens more.

 That history may point to a pattern of FDA concern about the category's advertising, even though the FDA isn't a party to this suit.

The impact of the lawsuit may be on the overall market going forward. Lilly may need to revise or pull the disputed ads regardless of how the litigation resolves, because a preliminary-injunction motion could force fast changes; closer FDA/OPDP attention to comparative dosing claims across the GLP-1 class, given the agency is already primed on this issue; and a precedent-setting effect for the category—comparative ads that don't reflect the newest approved doses become higher-risk from a liability standpoint, which could push both companies (and competitors entering the space) toward more conservative, label-aligned comparative.

Because the lawsuit doesn't touch production lines; chemistry, manufacturing, and controls filings; or supply agreements, its direct effect on manufacturing operations is minimal. But it may have a few indirect implications.

Both companies have spent the past 2 years pouring capital into expanding dosing options: Lilly has raised its Lebanon, Indiana investment past $9 billion largely to boost tirzepatide API and fill-finish capacity,

 and Novo Nordisk's roughly $16.5 billion Catalent acquisition (plus a related $11 billion site transfer) was explicitly aimed at growing Wegovy and Ozempic output.

 Novo's own investor guidance projects semaglutide manufacturing capacity growing about 50% from 2025 to 2027, concentrated specifically in fill-finish for higher-dose pens; the 2.4 mg and 7.2 mg Wegovy strengths and the 2 mg Ozempic pen have historically been the most fill-finish-constrained SKUs in the portfolio. The FDA's declaration that the Wegovy/Ozempic shortage had ended made it possible for these higher doses to be promoted at national scale.

 In that sense, the ad war is downstream of a manufacturing race: once fill-finish capacity caught up with demand for the newest, highest-potency doses, competition shifted from “can we make enough” to “whose highest dose wins the comparison.”

The market demand should see continued heavy capital allocation toward high-dose fill-finish and device (multi-dose pen) manufacturing on both sides, because dose strength has become the primary axis of both commercial and now legal competition. Second, this kind of dispute typically pushes companies to tighten internal coordination between manufacturing/supply planning, regulatory affairs, and commercial marketing, so that promotional claims don't reference doses that aren't yet fully available at scale or fail to reflect ones that are. Third, with the FDA already conducting a parallel crackdown on misleading GLP-1 promotion, manufacturers across the category may face more pressure to align launch communications timing with actual manufacturing ramp-up milestones rather than getting ahead of supply. All of this may reinforce dose-strength manufacturing capacity.

Novo Nordisk takes action to stop multiple misleading national GLP-1 advertising campaigns by Eli Lilly. Press Release. Novo Nordisk. July 21, 2026. 

https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916584

An introduction to trademark law in the United States. Congress.gov. Accessed July 21, 2026. 

https://www.congress.gov/crs-product/IF12456

Zubulake Z. New Wegovy dose approved under FDA’s CNPV. 

https://www.pharmtech.com/view/new-wegovy-dose-approved-under-fda-s-cnpv

Constantino AK. Novo Nordisk sues Eli Lilly, alleging misleading GLP-1 advertising. CNBC. July 21, 2026. 

https://www.cnbc.com/2026/07/21/novo-nordisk-sues-eli-lilly-glp-1-ads.html

Silverman E and Chen E. Novo Nordisk sues Eli Lilly over GLP-1 drug ads it calls ‘deceptive’. STAT. July 21, 2026. https://www.statnews.com/pharmalot/2026/07/21/novo-nordisk-sues-eli-lilly-glp1-drug-ads/

Lavery P. Lilly, Novo, Hims get FDA warnings about misleading drug communications. 

https://www.pharmtech.com/view/lilly-novo-hims-get-fda-warnings-about-misleading-drug-communications

Lilly commits additional $4.5 billion across Indiana manufacturing sites, opens first dedicated genetic medicine facility. Press release. Eli Lilly. May 6, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lilly-commits-additional-45-billion-across-indiana-manufacturing

Novo Holdings completes acquisition of Catalent. Press release. Novo Holdings. December 18, 2026. https://novoholdings.dk/news/novo-holdings-completes-acquisition-of-catalent

FDA declares Wegovy and Ozempic shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses. Novo Nordisk. Press release. February 21, 2025. 

https://www.prnewswire.com/news-releases/fda-declares-wegovy-and-ozempic-shortage-is-over-and-that-novo-nordisk-is-fully-meeting-or-exceeding-nationwide-demand-for-all-doses-302382370.html

GLP-1 Drug Manufacturing: Expansion & Tech Transfer. Intuition Labs. Accessed July 21, 2026. https://intuitionlabs.ai/articles/glp-1-drug-manufacturing-cdmo-tech-transfer

Articles

Novo Nordisk filed a Lanham Act and state unfair-competition suit in New Jersey alleging Eli Lilly’s DTC campaigns for tirzepatide mislead consumers by comparing against semaglutide at non-maximal, outdated doses. The claims focus on omission of FDA-approved Wegovy 7.2 mg (approved March 2026; STEP UP showed 18.8% mean weight loss vs 3.9% placebo) and Ozempic 2 mg maintenance dosing. Requested remedies include injunctive relief and corrective advertising. Direct manufacturing impact is minimal, but marketing and supply-aligned dose positioning may tighten.

Novo Nordisk’s complaint contends that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide) currently on the market.

Novo Nordisk Sues Eli Lilly Over Zepbound and Mounjaro Ads, Alleging Omitted GLP-1 Dosing Data

PharmTech Weekly Roundup—July 17, 2026

Some of this week’s highlights include the fact that the use of artificial intelligence is facing harder questions of governance and data quality. Regulators in the United States and the European Union are streamlining pathways to market. And on the plant floor, precision engineering still decides whether a product ships on cost and on spec.

, replacing a bioequivalence standard for topical corticosteroids and clarifying meeting procedures for OTC monograph sponsors. And the 

European Medicines Agency deepened ties with the EU's innovation agency

 to help small biopharma developers engage regulators earlier and head off late-stage manufacturing surprises.

 letting distributed “hub-and-spoke” manufacturing networks register as one establishment, while closing a registration gap for foreign API suppliers.

 produced a sustained complete response in a rectal cancer subtype, raising the possibility that some patients could avoid chemo, radiation, and surgery altogether.

AI and other digital technologies have received a lot of attention this week on PharmTech.com.

 isn't a content-generation problem, but rather a governance problem, requiring an “applicability engine” that keeps humans in control of downstream training and evidence.

, Richard Jaenisch of Open Biopharma, explains how Roche's GPU buildout and Sanofi's talent-first strategy target different AI bottlenecks, and that workforce trust not hardware is where most companies are stuck.

 finds AI reshaping pipelines toward high-value therapies, tariffs accelerating supply chain diversification, and the FDA's coming NDC-12 rule as a systems overhaul companies aren't ready for.

Rahul Mittal of Dr Reddy’s Laboratory makes the case that automation's next phase

 is connecting fragmented plant data through digital twins and electronic batch records so people can make better decisions.

And Arcana Life Sciences’ Remco Munnik, 

in an update on his 2026 industry predictions

, reports EU regulatory data reform is progressing, but AI adoption is still bottlenecked by weak data governance.

When it comes to quality considerations, 

Jeffrey Mocny of Abzena and Anna McMahon of Cellares,

 spoke with PharmTech’s sister publication, BioPharm International, about how risk-based quality management should be embedded into process design from day one to speed up biopharma development.

And Henrik Johanning, of Epista Life Science, 

provided PharmTech with a midyear industry review

. According to Johanning, Annex 1 is driving real capital investment in contamination control, while AI governance is clearer in principle than in practice.

, detailed how real-time force monitoring and dimensional verification assist high-speed pen injector lines in protecting costly drug cartridges while hitting above 99.5% first-pass yield.

 warned that oligonucleotide manufacturing's massive solvent volumes can push facilities into high-hazard building classifications, driving outsized costs.

Taken together, this week's stories point to an industry maturing in place: AI is being pushed to prove its governance and data foundations, regulators are removing friction without lowering the bar, and on the plant floor, the margin for error is still measured in fractions of a percent.

That's this week's roundup. For the full stories, visit PharmTech.com.

Videos

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market. 

Ask the Expert: Drug Approval Submissions

Could a pharmaceutical company’s regulatory affairs department become the target of a regulatory inspection? Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, say that it can, and companies that assume otherwise are exposing themselves to risk.

According to Schniepp, inspectors are not auditing the electronic submission mechanism itself because the eCTD system is already validated, and paper submissions are essentially obsolete in both the United States and the European Union. What's inspectable is the accuracy and completeness of the information within those submissions, and whether the company is following what it submitted. That scrutiny typically surfaces during chemistry, manufacturing, and controls (CMC)-focused inspections, such as pre-approval inspections, and becomes especially complicated when a company relies on a contract manufacturing organization (CMO) that may only have access to a fraction of the full submission.

Schmitt added that regulatory affairs departments function as a relay point: they receive condensed information, such as confirmation that an analytical method was validated per 

.), rather than the full underlying validation report. That compression creates risk. If information is incomplete, inaccurate, or garbled somewhere in the handoff from manufacturing to regulatory affairs (often through quality assurance as an intermediary), the resulting submission can be wrong. Inspectors, he noted, may specifically probe how communication pathways function between manufacturing sites, CMOs, and regulatory affairs.

Schniepp pointed to concrete gaps that often go unaddressed: submissions frequently state that a compendial method is used without including verification that the method actually works under the conditions in that specific lab. Similarly, when a proprietary test method is developed at an R&D site and later transferred to a manufacturing site, the tech transfer documentation supporting that move may not be part of the submission, raising the question of whether the company’s regulatory affairs department can answer for it if asked.

The conversation also covered the reverse information flow: feedback from regulators, such as an approved label change, must be communicated back into operations—to packaging teams, for instance—and executed correctly, particularly for companies managing multiple SKUs across many countries. Both panelists emphasized that inspectors have found regulatory affairs departments operating outside the company's quality system, mistakenly believing they're exempt from standard operating procedures (SOPs). Schniepp was unequivocal that regulatory affairs must operate within the quality management system, even though quality doesn't dictate every regulatory task. Any change must go through formal change control and be supported by documentation in the submission or a subsequent update; undocumented changes put the entire validated process in question.

Schniepp raised a further liability: regulatory affairs departments receiving clinical data must have some means of confirming that data have not been falsified. Cases exist where fabricated data made it into submissions because no one cross-checked it against the reporting site, and that gap becomes a serious liability once discovered.

Schmitt closed by noting inspections of regulatory affairs typically require a trigger—inspectors generally focus their attention on operational sites first. But especially in Europe, inspectors do verify that what's stated in the license matches actual site practice. He recommends that processes be kept as simple and robust as possible, because complexity is what generates gaps. His practical recommendation for manufacturers: ensure regulatory affairs staff are properly trained, operate under clear SOPs, and understand that they are not exempt from inspection scrutiny.

Click the above video to watch Sue and Siegfried answer the following question:

“Our regulatory affairs department handles all the submissions to regulatory agencies. Is there a chance the department may be inspected?”

Susan J. Schniepp is distinguished fellow at Nelson Labs and a member of 

Siegfried Schmitt is vice president, Technical at Parexel and a member of 

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, explain a company’s regulatory affairs department is subject to inspections by regulators and should, therefore, be prepared.

test tube ampoule syringe flag europe doctor vaccine medicine | Image Credit: ©NataliAlba -stock.adobe.com

The European Medicines Agency (EMA) announced on July 15, 2026 that it has strengthened its relationship with the European Innovation Council and SMEs Executive Agency (EISMEA) to help early-stage biopharmaceutical and medical technology developers engage with European Union regulatory requirements earlier in the drug development process.

 EMA’s Executive Director, Emer Cooke, and EISMEA’s Director, Momchil Sabev, signed a letter of intent formalizing a relationship the 2 organizations have maintained since 2021. The agreement is paired with a rolling work program for 2026–2027 that turns shared goals into specific joint activities.

EISMEA administers the European Innovation Council, which funds high-risk, high-potential research across the EU, including biotechnology and health technology projects. Since the two organizations began working together, their joint efforts have focused on helping innovators move early-stage research toward medicines and health technologies that satisfy European regulatory standards.

What the Partnership Means for Drug Developers

The reinforced agreement targets small and medium-sized enterprises, start-ups, spin-offs, research organizations, and universities with training, awareness campaigns, outreach, and support services designed to clarify regulatory expectations earlier in a product's development.

“Enabling innovation is central to our public health mission to bring new treatments to patients,” Cooke said in a press release.

 “Our collaboration with EISMEA helps us better support innovators to address unmet medical needs, improve health outcomes and strengthen Europe's competitiveness.”

According to Sabev, early regulatory engagement changes how innovators plan their development programs.

“The earlier health innovators can engage with regulatory expertise, the better equipped they are to make informed development decisions, reduce risk and achieve our shared objective: to get innovative solutions to patients,” Sabev said in the press release. “This partnership is another step in creating the conditions that allow Europe's most promising companies to succeed.”

Going forward, the 2 organizations plan to continue regulatory-readiness work for emerging health technologies, support projects funded by the European Innovation Council, and expand training, education, and stakeholder engagement activities aimed at improving understanding of the regulatory framework among funded innovators.

The agencies point to early results from their existing collaboration. According to a joint feedback survey, three-quarters of European Innovation Council-funded innovators said their awareness of the EMA’s support tools increased after participating in joint training activities. Respondents said the tools had a positive effect on both product development and regulatory strategy, and 95% said they would use them again for future projects.

Why This Matters for Pharmaceutical Manufacturers

For manufacturers, particularly smaller biopharmaceutical and medical technology companies without dedicated regulatory affairs teams, earlier access to regulatory guidance may reduce the risk of late-stage surprises tied to chemistry, manufacturing, and controls requirements. Complex modalities such as cell and gene therapies, personalized medicines, and products that combine drugs with digital or artificial intelligence components often carry manufacturing and quality considerations that are difficult to retrofit once a development program is already underway.

By connecting funded innovators with regulatory expertise before pivotal studies and scale-up decisions, the partnership could help smaller developers build manufacturing and quality strategies that align with European expectations from the outset, rather than adjusting them after regulatory feedback arrives late in development. That alignment matters for an industry increasingly focused on advanced therapies and novel manufacturing platforms, where regulatory and manufacturing complexity tend to compound each other.

The initiative also reflects a broader push within European Union pharmaceutical policy to support smaller developers, a priority also visible in the ongoing overhaul of the bloc's pharmaceutical legislation and in proposals for regulatory sandboxes covering advanced therapies, digital health tools, and novel antimicrobials.

EMA and EISMEA boost cooperation to accelerate health innovations. Press release. EMA. July 15, 2026. 

https://www.ema.europa.eu/en/news/ema-eismea-boost-cooperation-accelerate-health-innovations

EMA welcomes political agreement on new EU pharmaceutical legislation. Press release. EMA. December 11, 2025. Accessed July 15, 2026. 

https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation

EU overhauls pharmaceutical law with sweeping 2026 reform package. Osborne Clarke. March 31, 2026. Accessed July 15, 2026. 

https://www.osborneclarke.com/insights/eu-overhauls-pharmaceutical-law-sweeping-2026-reform-package

Haigney S. EMA calls new EU pharma legislation most significant in two decades. PharmTech.com. December 12, 2025. 

https://www.pharmtech.com/view/ema-calls-new-eu-pharma-legislation-most-significant-in-two-decades

EMA and EISMEA formalized an expanded collaboration via a July 15, 2026 letter of intent and a 2026–2027 rolling work program to embed regulatory readiness earlier in EU-funded health innovation. The initiative targets SMEs, start-ups, spin-offs, and academic developers with training, outreach, and support services to clarify EMA expectations. Early engagement is positioned to de-risk development and accelerate translation of high-potential research into approvable products. Surveyed innovators reported increased awareness of EMA tools, perceived strategic benefit, and high intent to reuse supports.

EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.

EMA and EU Innovation Agency Deepen Ties to Speed Up Drug Development

A top view of medicine powders, liquids in containers, and various manufactured medicine on the American flag. An America pharmaceuticals concept. | image Credit: ©Ming -stock.adobe.com

On July 10, 2026, the FDA announced a proposed rule to streamline registration for single distributed manufacturing establishments that operate using a “hub-and-spoke” model.

 The proposed rule would create a streamlined pathway and clarify registration requirements for certain foreign companies that manufacture APIs and drug products that indirectly enter the US drug supply. In addition, it would help reduce registration costs and generate efficiencies, according to the agency.

Currently, distributed manufacturing establishments use a central quality oversight hub with multiple manufacturing units in different locations and must register each of those units with the FDA separately. The new rule would allow the establishment to register as one unit.

Certain foreign drug manufacturing companies, such as those not registered with the FDA that distribute to other foreign establishments, would see registration and drug listing requirements clarified under the rule. “By aligning our regulations to the statutory requirements, this proposed rule would make it clearer that these establishments must register with the FDA and report on the drugs they produce, giving the FDA greater ability to detect and respond to potential safety concerns,” the agency stated in the press release.

“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works—as one single establishment,” said Michael Davis, MD, PhD, acting director of FDA’s Center for Drug Evaluation and Research, in a press release.

 “The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”

Because each unit in a distributed manufacturing network currently has to register separately with the FDA, this complicates administration for those companies that run a central quality hub with multiple production units. This proposed rule would provide a single-registration pathway, and the network could register as one establishment, allowing for a streamlined process for adding, relocating, and removing units. This change would support newer manufacturing models such as modular and continuous manufacturing operations. However, companies would be required to give the FDA advanced notice of any unit relocations.

The rule may close a registration gap for some foreign manufacturers of APIs and other drug components, allowing for broader supply-chain transparency and traceability upstream. Currently foreign facilities that make drug components solely for further distribution to other foreign establishments have been able to avoid registration in the United States, because the product never directly enters the US supply chain at that stage.

“When an active ingredient in a medicine reaches an American patient, the FDA should be able to trace exactly where it came from,” said Dr. Davis in the press release.

 “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”

Because this rule could cut registration overhead once finalized, any company sourcing APIs or intermediates from foreign suppliers that currently sit outside the registration net should expect those suppliers to face new registration/listing obligations, which could affect supply chain audits and sourcing decisions.

The Link Between Ingredient Suppliers and the Supply Chain

If this new rule impacts suppliers, it could impact a supply chain that is already strained, but it could also help protect it. The drug supply chain may be disrupted by a variety of factors, such as geopolitical impacts, manufacturing quality deficiencies, and a breakdown in ingredients supplies. If a drug is in shortage, patients cannot get the treatment they need.

The US Pharmacopeia released their annual drug shortages report in June 2026, which found that while shortages were down, they were lasting longer.

“More than half (64%) of the drugs in shortage have been in shortage for more than 3 years, with 29 (39%) drugs being in shortage for more than 5 years,” the report states.

 “Increased durations of drug shortages are a critical public health risk that can lead to compromised patient care, treatment delays, and unfavorable outcomes. Without intervention, prolonged shortages will continue to directly burden patients and healthcare providers.”

And generic drug manufacturers were specifically impacted.

“Manufacturers of generic drugs and their ingredients operate on thin, sometimes unsustainable margins,” said Matthew Christian, director of Supply Chain Insights at USP, in the press release.

 “This report shows a relationship between prices received by manufacturers and continued production. Product discontinuations add to supply fragility and risk of future shortages if supply cannot meet demand.”

PharmTech spoke with Gabriela Grasa Mannino

, senior director, Advanced Supply Chain Solutions at USP about the current state of the drug supply chain and what actions USP is taking to make supply more secure.

“The nature of supply chain risks has also changed, as they are no longer exclusively episodic. We have moved from disruptions driven by isolated events to a more persistent, systemic level vulnerabilities,” Mannino told 

 “Today, manufacturers operate in a more dynamic and less predictable environment, where disruptions are harder to anticipate and increasingly complex to manage. Looking ahead, these challenges are likely to persist, especially for products that rely on concentrated or highly specialized production. This really reinforces the need to address the underlying system, not just react to the outcomes.”

FDA proposes rule to modernize drug manufacturing registration. FDA. Press release. July 10, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration

USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026. 

https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk

Mannino GG, Haigney S. The role of standards in the drug supply chain. 

https://www.pharmtech.com/view/the-role-of-standards-in-the-drug-supply-chain

FDA proposed a rule enabling “hub-and-spoke” distributed manufacturing networks to register as a single establishment rather than registering each manufacturing unit separately. The approach aims to reduce administrative burden, better reflect centralized quality oversight, and support modular and continuous manufacturing, while requiring advance notice for unit relocations. The proposal also clarifies registration and drug-listing expectations for certain foreign API and component manufacturers that have historically sat outside FDA registration. Expanded upstream transparency may influence supplier qualification, audits, and sourcing amid prolonged drug shortages and fragile generic economics.

A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments. 

The FDA Moves to Modernize Drug Manufacturing Registration

PharmTech Weekly — July 10, 2026

This week, regulators, dealmakers, and manufacturers converged on the same demand: greater accountability and resilience across drug development and manufacturing. From phased and accelerated regulatory reviews, to enforcement on artificial intelligence (AI)-assisted documentation, to acquisitions built to close capability gaps, the pressure is on to build systems that are faster, better controlled, and more transparent.

In regulatory news this week, the European Medicines Agency’s (EMA’s) 

 for metastatic pancreatic cancer previews how legislative reform for pharmaceuticals in the European Union may help regulators assess quality and clinical data in stages, compressing timelines without lowering the evidentiary bar.

, the first dual BAFF and APRIL inhibitor for IgA nephropathy, highlights the pairing of self-administered specialty biologics with near-term confirmatory data requirements.

, worth up to $1.5 billion, is the next in a string of deals showing that payload and linker chemistry, not just antibody targeting, are driving competitive differentiation in next-generation ADCs.

And finally, Teva and Polpharma Biologics’ 

 biosimilar expands access to specialized biologics in the multiple sclerosis market.

Industry experts took a look at a variety of topics this week on 

 explained how the FDA’s warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting of good manufacturing practice (GMP) documents still requires quality-unit review, controlled source material, and process validation performed by experts.

 explained that drug shortages often stem from geographic concentration and quality variability, and that standards paired with data-driven risk assessment are key to building supply chain resilience.

 about the role of variability in patient-derived starting material. The experts suggested that variability can’t be standardized away and requires risk-based control strategies and clinically representative data to keep autologous manufacturing robust.

 argued that patient-centered formulation, 3D-printed dosage forms, and AI-driven development are coming together to make personalized, preventive medicine achievable, as long as the underlying data are well managed.

Contract research organizations are being encouraged to replace manual, disconnected workflows with automation and integrated systems, because efficiency and data integrity define competitive advantage, 

, Lonza Capsugel’s Jamie Evans and Joe Cobb emphasized that successful sponsor-to-CDMO technology transfer depends on rigorous gap analysis, quality-by-design planning, and strong governance to avoid regulatory and supply delays.

The message from industry experts and regulators is consistent this week: speed and innovation only hold up when they’re backed by rigorous control, data, and collaboration.

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.