Christopher Cole

We highlight the week’s industry news in an easy-to-consume, fun format.

PharmTech Weekly Roundup – Week of September 8, 2025

In this new PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage.

Collectively, the week’s coverage discusses critical trends and advancements in the pharmaceutical industry, primarily focusing on insights from the 

, held September 8-10 in Washington, DC. A significant theme across our conference coverage is the increasing integration of artificial intelligence (AI) into various aspects of pharmaceutical operations, including 

, emphasizing the need for robust data governance, human oversight, and regulatory compliance.

We also address the importance of quality assurance and adherence to FDA regulations, detailing 

, strengthening responses to inspection findings, and fostering a strong quality culture from leadership down. Additionally, there are discussions on 

digital transformation in workforce training

, highlighting how modern learning management systems, virtual reality, and AI can enhance practical skills and continuous learning within the industry. Check out our interview with key PDA experts who provide 

.

Outside of our PDA Regulatory Conference coverage, we present real-world data on a 

, showcasing its comparable effectiveness to traditional injections and its approval as a non-injection alternative for anaphylaxis; the European Commission's decision to 

continue allowing titanium dioxide in medicines

, despite its ban in food; and findings from a 

 of 1000 senior executives across various sectors, identifying key priorities and challenges for supply chain resilience.

Videos

Pharma embraces AI for quality, supply chain, and training; navigates FDA compliance; and develops new treatments like an epinephrine nasal spray.

Dawn over Washington - with 3 iconic monuments illuminated at sunrise: Lincoln Memorial, Washington Monument and the Capitol Building | Image Credit © mandritoiu - stock.adobe.com

FDA is emphasizing a shift from checkbox compliance to a holistic, quality systems-focused approach in pharmaceutical manufacturing. During the 

, agency officials outlined expectations for companies responding to inspectional findings, from Form FDA 483 observations to post-warning letter remediation, during the session “Sustainable CGMP Remediation Plans and Communication: FDA Updates” (1). Discussions highlighted that compliance is not merely a regulatory burden but a strategic investment that drives operational excellence and strengthens competitive advantage. These themes, along with FDA insights and compliance trends, were widely covered, as seen in articles from pharmtech.com on the conference, including "

PDA Regulatory Conference Features More than 30 FDA Experts

Glenn Wright Highlights AI, FDA Insights at 34th Annual PDA Regulatory Conference

How is FDA compliance evolving for pharmaceutical manufacturers?

FDA officials noted that compliance is inherently focused on quality, science, and patient risk, rather than being a mere paperwork exercise. The agency seeks to foster an "anti-fragile" quality organization that can emerge stronger after problems are found, whether through FDA inspections, internal audits, or other external assessments. This perspective encourages companies to view inspectional findings as a catalyst for strengthening their systems. This aligns with insights exploring how to build resilience in pharma development (2). This transformation requires continuous improvement and a recognition that quality must be built in "by design," a principle echoed in manufacturing regulations and Deming's principles of management. Strategies for a smarter pharma workforce and digital transformation for regulatory training also support continuous improvement (3).

What are FDA's expectations for post-warning letter meetings?

Milind Ganjawala, a Division Director, DDQ, OMQ, OC, CDER, FDA

, stated that a reinspection is guaranteed to occur after a warning letter and will focus on systemic fixes, not just the specific items cited in the warning letter, which are often "a very small snapshot" of potential issues. He emphasized a "holistic view" and a "quality systems improvement approach," encouraging companies with multiple facilities to apply the lessons learned across their entire organization.

To be eligible for a post-warning letter meeting, a facility must have current good manufacturing practices and an Official Action Indicated compliance status from an inspection. The facility must also be current with its fees under the Food, Drug, and Cosmetic Act or be part of a pending application if it is an active pharmaceutical ingredient facility. These meetings are generally specific to 501-type warning letters related to good manufacturing practices violations.

When requesting a meeting, companies must demonstrate "actual implementation" of corrective actions, not just plans, noted Ganjawala, who stressed that progress should be "measurable" and geared toward remediation. He explained that the meeting package should include a robust root cause analysis for each warning letter item, an impact assessment on product quality and other systems, a comprehensive Corrective and Preventive Actions plan with realistic timelines, and evidence of implementation progress. The FDA reviews these requests and typically responds within 30 days, he added.

Denial reasons for meeting requests include missing Corrective and Preventive Actions plans, insufficient documentation of actual progress, a failure to establish a broader quality systems impact, or a lack of retrospective product quality assessment, continued Ganjawala, urging firms to "plan for the long game, not the quick fix."

How can pharmaceutical firms strengthen their 483 responses?

Tara Gooen Bizjak, Associate Director, GMP and Quality Standards, OC, CDER, FDA

, highlighted that a company's response to an FDA Form 483 is critical, serving as the "first impression" of how seriously findings are taken and providing a "visual demonstration of your site’s quality culture." While responding to a 483 is optional, it is invaluable for the FDA's evaluation of an inspection case. The importance of quality culture and FDA trends was a key highlight at the conference (1).

Effective 483 responses should demonstrate a vigilant, prevention-focused approach, rooted in a strong quality system that provides "broader stability" to the organization, continued Gooen Bizjak. The response should show "proactive leadership" and embrace a comprehensive evaluation, including systemic solutions and pertinent risk assessments. She noted that "helpful elements of a response include an executive summary demonstrating leadership’s commitment to quality, comprehensive risk assessment including patient and product impact evaluation, detailed investigation reports," and a diligent root cause analysis for each observation. It should also outline a Corrective and Preventive Actions plan with realistic, measurable milestones and include effectiveness monitoring.

Common pitfalls in 483 responses include minimizing the scope of findings, offering "quick fixes" without thorough root cause analysis, proposing unrealistic timelines, underestimating resource requirements, and poor communication, according to Gooen Bizjak, who cited examples from recent warning letters in which company responses were deemed inadequate due to high defect levels, lack of evidence for analytical method equivalency, failure to identify and implement appropriate Corrective and Preventive Actions from repeated sterility investigations, and an inability to address fundamental deficiencies in the quality unit.

What are key strategies for sustained pharmaceutical compliance?

Both speakers emphasized the importance of a comprehensive approach to quality and compliance. When a facility receives a 483 or a warning letter, it should trigger an examination of other facilities within the company to ensure they are in a sustainable state of compliance. They also suggested looking at publicly available warning letters and 483s to understand potential issues that might apply to one's own operations.

To improve investigations and root cause analysis, a common deficiency cited, companies should focus on sustainable solutions rather than quick fixes. Gooen Bizjak recommended ensuring that a "well-rounded team of subject matter experts" looks at issues to minimize bias in root cause determination and incorporate diverse perspectives. This approach is crucial for effective problem-solving (4). Managing compliance risks also benefits from such a comprehensive view (5).

Regarding organizational design, the FDA expects the quality unit to be independent and not report to production management, according to the presenters. They emphasized that senior management engagement is crucial, demonstrated by their physical presence on the manufacturing floor and their commitment to allocating necessary resources, shifting the mindset of quality from a "cost center" to an "investment." Ultimately, they encouraged firms to take ownership of their quality systems and continuous improvement, rather than relying on FDA to be their quality department. This approach leads to sustained compliance excellence and builds a quality system worthy of patient trust.

Building Resilience and Precision in Pharma Development

Navigating Regulatory Training: Digital Transformation Strategies for a Smarter Pharma Workforce

Effectively Using Contamination Control Strategies

Manufacturer Guidelines for the Secure Destruction of Controlled Substance Pharmaceuticals

Articles

The FDA is shifting its focus from mere compliance to a holistic, quality systems-focused approach in pharmaceutical manufacturing. This involves viewing compliance as a strategic investment that enhances operational excellence and competitive advantage. The agency emphasizes building resilient quality organizations that improve after inspections and encourages a comprehensive approach to addressing inspectional findings. Post-warning letter meetings require demonstrated implementation of corrective actions, while effective responses to Form 483 should reflect a strong quality culture. Sustained compliance involves independent quality units, senior management engagement, and a focus on continuous improvement.

FDA experts at PDA 2025 urges pharma to adopt holistic quality systems, strengthening 483 responses & post-warning letter remediation for compliance excellence.

PDA 2025: FDA Experts’ Proactive Strategies for Mastering 483 Responses 

Businessman hand pressing button Training. sign on virtual screen. business Mentoring Learning Education Browsing concept | Image Credit: © NaMong Productions - stock.adobe.com

Optimizing training for performance in the pharmaceutical industry was a key theme at the PDA Regulatory Conference 2025, with discussions centered on moving beyond basic compliance to leveraging digital tools for more relevant and responsive learning. Industry experts Marc Glogovsky and Richard Jaenisch shared insights on the evolution of training methodologies and the potential of new technologies on Monday, September 8, 2025 in the session “Competency-Based Training and Digital Learning,” moderated by PharmTech editorial adivisory board member and 

 co-host Susan Schniepp, fellow, Regulatory Compliance Associates.

Why is training for performance a necessity in regulated industries?

Training is more than a checkbox; it is a legal requirement, said 

Marc Glogovsky, Business Unit Manager of Microbiology at ValSource, Inc

., who emphasized that every person involved in operations must receive job-specific, ongoing training in Good Manufacturing Practices (GMP), delivered by qualified individuals. Unfortunately, training sometimes devolves into rote exercises lacking relevance. As Glogovsky observed, employees question modules like “lockout tagout” that have little practical connection to their duties. Effective training, he stressed, ensures personnel are “fit for purpose.”

This isn’t just theoretical. In 2024, there were 27 FDA 483s citing training deficiencies among 561 total for drug products, Glogovsky noted, a trend seen year after year. “If you're not giving them the proper tools, the proper training… you’re going to get some type of half-assed response… not in line with what the [GMP] expectations are,” he stated.

What are the common challenges facing traditional training programs?

Both speakers acknowledged major obstacles in traditional training. Glogovsky cited the overwhelming number of regulations across GMP, good clinical practice, good distribution practice, etc., skill gaps caused by evolving roles, rapid tech shifts, and high employee turnover. In-person training often strains resources, leads to disengagement, and can cause “burnout” for instructors and learners alike, he added. As Glogovsky joked, “If you give me training at 10:00 on a Monday, it's going to be a good day; you give that to me at 4:59 on a Friday, good luck.”

Richard Jaenisch, Director of Education and Outreach at Open Biopharma Research and Training Institute

, echoed these points, stressing the “human factor,” noting that people switch organizations, and systems’ needs change swiftly.

How can digital transformation elevate learning management systems?

Digital learning management systems (LMSs)—from 

—are central to modernizing training. Jaenisch explained that these systems, accelerated by the COVID-19 pandemic, simplify audit readiness, allow easy tracking, and enable learning “anywhere, anytime.” Interactive features like quizzes within videos and global accessibility are advancing continuously. Micro-certifications are also becoming standard for validating workforce skills.

What roles do VR and AR play in practical skill development?

Virtual Reality (VR) and Augmented Reality (AR) transform hands-on skills training, said Glogovsky, who found VR “eye opening” for cleanroom work, letting staff see how actions alter airflow in a way impossible to replicate in person. Jaenisch described VR as invaluable for onboarding, reducing risk and costs, and supplying critical feedback on techniques like aseptic manipulation.

AR is a game-changer for “digital work instruction,” they both agreed. With AR, protocols and schematics overlay live equipment, and trainees can practice virtually using digital twins of facilities—essential for complex, unfamiliar tasks and equipment.

Is gamification an effective strategy for enhancing engagement?

Gamification applies game mechanics—points, badges, leaderboards—to increase engagement. Glogovsky noted it can “be quite engaging,” turning even reticent operators competitive. Yet Jaenisch cautioned that gamification doesn’t motivate everyone, joking that “Some people don't need no stinking badges” and explaining that misapplied gamification may favor “addiction over utility,” distracting from true learning. Extrinsic motivators like financial incentives and time off often work better, and gamified elements need purposeful, personalized integration.

How can generative AI revolutionize training content and delivery?

Generative artificial intelligence (AI) is reshaping workforce training, said Jaenisch, who called it one of the “two big fundamental changes” in digital learning. Key AI applications that he noted include:

Content summaries: AI rewrites standard operatice procedures (SOPs) or training content for clarity and accessibility, especially for non-native English speakers.

Quiz generation/assessment: Automated, adaptive quizzes measure understanding instantly.

Personalized learning: AI fine-tunes curricula to individual needs.

24/7 feedback: Intelligent tutoring systems can support learners in real-time, offering tailored guidance.

At Open Biopharma, digital interactive SOPs use AI to analyze quiz answers deeply, giving specific feedback, even for partially correct responses, and tracking progress in detail. Glogovsky also noted AI’s usefulness for generating training visuals and materials.

What are the barriers to adopting new digital training tools?

Despite digital potential, adoption is challenging, according to Jaenisch, who pointed to the high costs of LMS and AI tools—an LMS can run tens of thousands of dollars, while sophisticated generative AI can cost hundreds of thousands to millions, he added. Implementing these systems demands robust data infrastructure, regulatory clarity (often lacking or inconsistent between the US and EU), and organizational readiness for change.

What does the future hold for biomanufacturing training?

Looking ahead, biomanufacturing training is moving toward a “unified, intelligent learning ecosystem.” Centralized LMS platforms, integrated VR/AR for skills building, carefully applied gamification, and micro-certifications will define future models. Overcoming obstacles hinges on phased pilots, commitment to compliance and talent growth, security by design, and ongoing measurement.

A digital-first mindset—rooted in compliance, ethics, and relentless improvement—will grow a skilled workforce. Glogovsky advocated, “I would like to see training done every day—don’t just slam someone with 75 days of training into one week.” Breaking training into daily sessions supports mentoring, sharing, and transparency. Jaenisch’s group plans daily 20-minute sessions with generative AI, enabling continuous learning and real-time progress tracking for both individuals and teams.

Optimizing training in the pharmaceutical industry is crucial for compliance and performance, with digital tools enhancing learning experiences. Industry experts emphasize the need for job-specific, ongoing training to meet Good Manufacturing Practices (GMP) standards. Traditional training faces challenges like resource strain and disengagement, while digital learning management systems (LMSs) offer flexibility and audit readiness. Virtual Reality (VR) and Augmented Reality (AR) enhance practical skills training, and generative AI personalizes learning. Despite high costs and regulatory challenges, a digital-first approach promises a unified, intelligent learning ecosystem for biomanufacturing.

Glenn Wright previews the 34th PDA/FDA Regulatory Conference, spotlighting AI, quality culture, FDA trends, and collaboration shaping industry progress.

PDA President and CEO Glenn Wright highlights the significance of the 34th Annual PDA Joint Regulatory Conference, noting his long-standing connection to the event: “I was actually chair of this conference when it was year number five… I've been involved with PDA for 36 years.” He praises the alliance between industry and regulators, emphasizing that “we really have kind of a nice industry-FDA collaborative conference.”

This year’s agenda captures emerging trends, including artificial intelligence (AI) in manufacturing and compliance. Wright shares his enthusiasm: “I always talk about the tidal wave of AI and data analytics that's gonna be hitting the industry. It really is good for the patient. It really means we have more control of the processes.” Attendees can also expect sessions on quality culture, effective remediation, and the critical roles of CDMOs and CMOs in modern manufacturing.

The conference remains a vital source for regulatory updates. “Some really great updates from FDA, really talking about trends that they're seeing, which is really important for the industry as a whole to understand what's going on out there,” notes Wright. He concludes with optimism, adding “We're just really excited. It's gonna be, I think, a hugely successful conference again for year number 34.”

Check out all our 

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.


Glenn Wright, I'm the president and CEO of PDA.

Well, I'm really excited about this year's conference, our 34th regulatory conference. I can remember, quite some time ago, I was quite new to the industry and I was actually chair of this conference when it was year number five. So that should tell you I've been involved with this conference for quite a long time.

I've been involved with PDA for 36 years. You know, every year this conference surprises me because there's always exciting things that are going on in the industry and it kind of captures that, as well as with the heavy FDA involvement. We really have kind of a nice industry FDA collaborative conference, and this year, the topics are diverse. I mean, we're gonna be talking about AI in manufacturing, which I am really excited about. We're also gonna be talking about AI in auditing. I just got done doing a presentation on that topic. It's really incredible when you think about what AI may do in that whole auditing area in regard to looking at data, looking for anomalies, trying to find challenges that a company may have or an area may have, you know, so that's gonna be kind of exciting to me 'cause we see that AI space just continuing to grow. And then just AI in manufacturing, right, because again, you know, if we're thinking about product quality, once we get AI in manufacturing—and it's really ramping up, right. So I think I always talk about the tidal wave of AI and data analytics that's gonna be hitting the industry. It really is good for the patient. It really means we have more control of the processes. So that's just one small area I'm excited about.

I'm also excited about the talks on quality culture and really how to implement quality culture. I think that's fantastic. And there's a couple talks on remediation. So, you know, once you've had challenges and now you're gonna have to remediate those challenges, how do you go about that? How do you develop your plan? Some exciting things there. Again, it covers so many things, supply chain is on there, supply chain disruption, some discussions around use of contract services, so CDMOs and laboratories, and that's really important for the industry now as we see continued increases in the use of CDMOs and CMOs. They're so important because they have the technology that we need a lot of times, and so as new products get more and more complex, a lot of times those CDMOs and CMOs are just critical for that operation. But how do you manage that and how do you make sure you've got enough control over your contracted operations? So, some discussions on that, which I think are gonna be really exciting. I always like group topics, around the pre-approval inspections and what can you kind of expect in pre-approval inspections and what are the trends? So, we're gonna have some topics on that.

And of course, as we do every year, some really great updates from FDA, really talking about trends that they're seeing, which is really important for the industry as a whole to understand what's going on out there, what are they seeing, because when we think about FDA, you know, we have to remember that they see everything. They're the ones that can really help industry by letting us know what kind of trends are going on, what are they seeing as they go out and do inspections or what they see during submission reviews.

Another great topic this year is gonna be on post-approval changes, which, you know, for me being in regulatory for many, many years, is really exciting because we always kind of forget how important the post-approval change process is, how we need to navigate that carefully. You know, it can take years when you think globally about making a change and getting it approved by all the different countries. So that whole PAC (post-approval change) process, I'm really excited to see that topic on this year's agenda as well.

You know, I think the biggest takeaways from this year's conference, I think they're probably gonna come from the FDA speakers as they talk about some of the things they're seeing, some of the challenges they're seeing. That's always kind of the case. I think in this conference, we hear really great things from industry, kind of some practical approaches on how to do things, how to implement things, and that's really great, but there's always those great nuggets that come out of the agency in regard to things they're seeing and the expectations they have. And, so I think, those two areas… really excited to see what comes out. 

I never quite know, you kind of got to be there, you got to go through the presentations to understand everything. So, I think, on the back end of this, I'm sure I'll have some, nuggets that we've gained from the conference, but we're just really excited. It's gonna be, I think, a hugely successful conference again for year number 34. Again, FDA is heavily engaged in this conference, as is industry. And we've got folks all the way from heads of manufacturing to heads of quality talking—all kinds of folks from the agency, so I really think it's gonna be a great conference.

Glenn Wright previews the 34th PDA Regulatory Conference, spotlighting AI, quality culture, FDA trends, and collaboration shaping industry progress.

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

The Parenteral Drug Association (PDA) Regulatory Conference, marking its 34th year, will offer a forum for dialogue between global regulators and industry professionals from the pharmaceutical sector (1). Though FDA is not an official co-sponsor of the 2025 event, more than 30 FDA experts will participate as speakers, moderators, and panelists, underscoring significant agency support. The conference theme, “Achieving Current Good Manufacturing Practice Excellence: Sustainable Compliance Across the Lifecycle,” directly addresses core challenges and objectives for professionals in pharmaceutical manufacturing and development. This sustained engagement from FDA leadership provides crucial opportunities for the industry to deepen its understanding of regulatory expectations and evolving compliance landscapes.

Understanding FDA priorities and compliance trends

A key focus will be the second plenary session on the first day, dedicated to current good manufacturing practice compliance trends and topics (2). This session is particularly relevant for professionals seeking to strengthen their compliance frameworks and advance their quality systems to meet global standards. Speakers will include Francis Godwin, Director, Center for Drug Evaluation and Research (CDER) Office of Manufacturing Quality; Jonathan Swoboda, Consumer Safety Officer, Center for Biologics Evaluation and Research (CBER) Office of Compliance and Biologics Quality; Jeffrey Meng, Associate Director, Emerging Technologies and Advanced Manufacturing, Office of Inspections and Investigations (OII) Medical Products Inspectorate; and Dillard Woody, Branch Chief, Center for Veterinary Medicine (CVM) Office of Surveillance and Compliance. Their presentations will offer detailed insights into the latest compliance trends, which is essential for maintaining regulatory adherence and ensuring patient safety. Following this, FDA officials are scheduled to contribute as speakers and panelists across most breakout sessions, providing further detailed discussions on various topics (2).

Navigating regulatory challenges and enforcement outlook

The third day of the conference will feature “Plenary 4: Regulatory Priorities and Enforcement Outlook,” a session critical for professionals seeking to understand FDA’s focus areas and potential enforcement actions (2). This plenary will feature presentations from Melissa Mendoza, Director, CBER Office of Compliance and Biologics Quality; Jill Furman, Director, CDER Office of Compliance; Cindy Burnsteel, Deputy Director, Drugs and Devices, CVM Office of Surveillance and Compliance; and Ivy Sweeney, Acting Director, Office of Human and Animal Drug Inspectorate, OII. Anticipating these regulatory shifts and enforcement postures is vital for proactive strategic planning and risk management.


Additionally, a preconference roundtable hosted by the PDA’s Capital Area Chapter on Sunday, September 7, focused on FDA Complete Response Letters (CRLs) (2). Thomas Cosgrove, former Acting Director, CDER Office of Compliance, led discussions examining the increasing frequency and significance of CRLs. This session provided a timely overview of the challenges these letters pose and their implications for regulatory strategy and operational readiness in drug development, directly impacting the timelines and resource allocation for new product applications. Registration fees for this roundtable are being directed to the PDA Jette Christensen Early Career Professional Grant, supporting the next generation of leaders in the pharmaceutical sector.

The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda

The 34th Parenteral Drug Association Regulatory Conference will facilitate dialogue between global regulators and pharmaceutical industry professionals. Despite not being an official co-sponsor, the FDA will have over 30 experts participating, highlighting its support. The conference theme focuses on achieving excellence in current good manufacturing practices. Key sessions will address compliance trends, regulatory challenges, and enforcement outlooks, featuring prominent FDA officials. A preconference roundtable will discuss FDA Complete Response Letters, emphasizing their impact on regulatory strategy and drug development timelines, with proceeds supporting early career professionals.

The PDA Regulatory Conference convenes more than 30 FDA experts to discuss cGMP excellence, compliance trends, and regulatory outlook, offering crucial insights for pharma manufacturing professionals.

In this new PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format

PharmTech Weekly News Roundup - Week of September 1, 2025

In this new PharmTech video feature, we’ll highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

Cytokinetics' Aficamten, a cardiac myosin inhibitor, 

significantly outperformed metoprolol in a Phase III trial

 (MAPLE-HCM) for obstructive hypertrophic cardiomyopathy, demonstrating superior efficacy in improving exercise capacity, symptoms, and left ventricular outflow tract gradients.


The European Medicines Agency and the World Health Organization are 

celebrating a decade of successful collaboration

 aimed at enhancing global regulatory capacity and public health.


The University of Oxford and the Ellison Institute of Technology launched the 

Correlates of Immunity—Artificial Intelligence program

, a £118 million (US$158 million) initiative focused on understanding immune responses and vaccine protection against antibiotic-resistant pathogens.


Concerns are rising in the US over the removal of key advisory figures, including 

Paul Offit, from FDA vaccine advisory committee

 under HHS Secretary Robert F. Kennedy Jr.


Finally, the Pistoia Alliance announced an 

 to establish standards and protocols for the safe and responsible adoption of "agentic AI" in the life sciences.

Aficamten beat metoprolol for oHCM, EMA/WHO hit 10 yrs, Oxford and EIT collaborated on AI vaccine, Offit's FDA exit stirred policy, and Pistoia set agentic AI rule.