Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Jill Wechsler

The coming year promises to embroil federal health agencies, providers, and biomedical research organizations in a range of contentious issues, as promising research on breakthrough therapies confronts policymakers looking to limit government spending on public health, R&D, and regulatory operations. Politics also will shape global health initiatives to combat antimicrobial resistance and to prepare for future pandemics, while drug coverage and costs remain a hot topic. FDA’s accelerated approval program will be in the spotlight, with manufacturers facing more pressure to withdraw from the market products that fail to confirm efficacy in timely postapproval studies. Drug shortages will also continue
to draw attention and proposed remedies, as rising infection rates send patients to hospitals and drive a surge in demand for treatments.

An anticipated end in 2023 to the public health emergency adopted two years ago to facilitate the approval of new treatments and preventives to COVID-19 will limit FDA emergency use authorizations (EUAs) that have helped speed promising treatments to patients. The change also may limit telehealth flexibilities and broader healthcare coverage for lower income patients.

At the same time, FDA faces tight deadlines for implementing a host of new programs and policies established by recently reauthorized user fee legislation for drugs and medical products. These include initiatives to modernize manufacturing processes and for testing innovative therapies and monitoring their effects. Looking ahead, 2023 promises to be a big year for cell and gene therapies, as seen in FDA’s formation of an expanded Office of Therapeutic Products to handle the surge in regenerative, genetic, and messenger RNA therapies.

Additionally, FDA and industry face a November 2023 deadline for full implementation of the Drug Supply Chain Security Act. This ten-year-old program requires all prescription drugs to be traceable from manufacturers to distributors and pharmacies, but it has been difficult to establish and has been subject to multiple delays.

These and other FDA initiatives require the agency to attract hundreds of new scientists and analysts able to evaluate innovative therapies, handle complex regulatory requirements, and monitor manufacturing operations needed to ensure quality standards. The likely retirement of dozens of senior staffers, moreover, will further challenge agency capabilities.

Notable changes in Congress promise to alter the tone and substance of the legislative debate and put pressure on federal funding of healthcare and biomedical research. New GOP committee chairs in the House are readying probes of Biden administration mismanagement of the pandemic and failure to fully assess the Chinese origins of COVID-19. Republican promises to reduce federal spending also threaten anticipated increases in budgets for FDA, the National Institutes of Health, and Medicare and Medicaid. Cost-cutting for Medicare includes an increase in the eligibility age for seniors, reduced payments to providers and hospitals, and further revisions in Medicare reimbursement and coverage of prescription drugs.

Although Democrats continue to control the Senate, there will be notable changes at the Senate Health, Education, Labor, and Pensions (HELP) Committee, as Sen. Bernie Sanders of Vermont is in line to become chair. Sanders has long championed universal health care and attacked high drug costs, and it remains to be seen where he can gain support from Republicans on the panel.

The battle over abortion drugs will continue to escalate, with pro-life organizations challenging FDA’s approval of mifepristone based on alleged inadequate safety testing. While the suit appears weak to legal experts, this attack strategy will consume considerable agency attention and resources. The fight is slated to go global, moreover, as some advocates work to increase access to abortion pills in other countries, while others seek curbs on abortion access.

Continued Democratic control of the Senate makes it unlikely that Congress will revise the provisions in the Inflation Reduction Act (IRA) that authorized Medicare price negotiations, curbs on certain drug price increases, and a price cap on insulin for Medicare beneficiaries. Democrats still want to extend the insulin cap and price hike limits to all patients, but that may be too costly to advance. Sky-high launch prices on new treatments, though, draw criticism, as seen in the $3.5 million list price for CSL’s new hemophilia B gene therapy (1). FDA leaders are exploring if less costly clinical testing strategies could reduce development costs for such bespoke therapies.

In the name of reducing outlays for medicines, some states will continue to push for FDA authorization of drug import plans, as permitted by policies adopted during the Trump administration. Several states have devised such Canadian drug import programs, but so far, FDA has not approved any due to continued concerns that the administrators cannot prevent distribution of unsafe or unregulated products.

Pharmacy benefit managers (PBMs) also will be in the spotlight, as Congressional leaders move to examine their role in drug access and pricing, issues already under investigation by the Federal Trade Commission (2). Both parties are reviewing the role PBMs play in determining patient outlays for drugs and in influencing Medicare drug coverage and costs.

While FDA avoids direct involvement in drug pricing issues, the agency will continue to support the development and marketing of generic drugs to promote market competition, particularly for products with complex formulations and dosage forms. Some members of Congress look to ensure that generic makers can access innovator products needed for testing and support efforts to advance the development of biosimilars by simplifying testing requirements for interchangeable therapies. The growth in follow-on treatments, though, promises to generate even more patent disputes, as will efforts to limit international patent protections strongly opposed by industry.

CBS News. FDA Approves Most Expensive Drug Ever, a $3.5 Million-per-dose Gene Therapy for Hemophilia B. 

FTC. FTC Launches Inquiry into Prescription Drug Middlemen Industry. Press Release. June 7, 2022.

Jill Wechsler is Washington reporter for 


Vol. 47, No. 1
January 2023
Pages: 14–15

When referring to this article, please cite it as J. Wechsler. A Rocky Road Ahead for FDA and Industry. 

Articles

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

A Rocky Road Ahead for FDA and Industry 

The year-end, must-pass government funding package includes multiple provisions important to FDA operations and authority, as well as for clinical research sponsors and pharmaceutical manufacturers. The $1.7 billion Consolidated Appropriations Act for 2023 will reshape Medicaid coverage and bolster pandemic preparedness and biomedical research, among dozens of measures involving drug development and regulation, as the legislators added hundreds of provisions sought by specific states and industries, but also left some key measures on the cutting-room floor.

FDA gains a notable funding increase, as well as multiple new policies and programs. The spending package provides the agency with a $6.6 billion total budget, a 6.5%, or $226 million, increase. That total includes $3.5 billion in appropriated funds plus $3 billion from authorized user fees paid by industry. A 

from Senate and House Appropriations Committees specifies that the added funds should be used to help end the opioid crisis, expand foreign drug inspections, fund orphan product development, advance medical device cyber security, and expand agency data modernization, inspections, and other programs. FDA regulation of human drugs will have $760 million in funds, while the budget for biologics is $272 million, as seen in a chart from the 

A leading provision overhauls FDA regulation of cosmetics to enhance product safety. To help states tackle the opioid crisis, the legislation aims to improve access to FDA-approved non-opioid therapies. Generic-drug makers gained provisions that prevent certain actions by brands designed to delay competition from generics and biosimilars. And to enhance diversity in clinical trials, the legislation instructs sponsors to submit “diversity action plans” for late-stage trials. FDA will issue more guidance on that process, hold public workshops on diversity issues, and report annually on progress in this area.

Probably the most high-profile FDA measure reforms the agency’s accelerated approval process. A key provision clarifies that agency reviewers may require that post-approval studies begin prior to product approval, but it does not require FDA to do so. The measure also speeds up the process for withdrawing drugs that fail to confirm anticipated benefits, while stopping short of mandating such action. Sponsors must provide updates on confirmatory trial status to the agency every six months, and a new FDA accelerated approval oversight council will weigh in on policies.

Missing from the massive bill, however, is a controversial provision that would have confirmed FDA authority to regulate diagnostic tests developed in clinical labs, including those at hospitals and academic medical centers. Although medical device makers and federal regulators backed the change as a way to clarify FDA authority in this area, the proposed VALID Act (Verifying Accurate Leading-edge IVCT Development) continued to raise objections from the labs and clinics.

The massive spending measure provides significant added funding for veterans’ health care, while also saving billions by ending Medicaid expansion policies adopted during the pandemic. The lawmakers extend telehealth waivers for two years, continuing to support telehealth practices useful to a number of FDA programs.

The Biden administration’s Advanced Research Projects Agency for Health gains $1.5 billion funding and will reside in the National Institutes of Health. Various provisions clarify its governance, reporting requirements, leadership, and collaborations with FDA.

The legislation further aims to enhance biosecurity programs to better prepare the nation’s capacity to combat future viral epidemics and biological threats. There is increased funding for the Biomedical Advanced Research and Development Authority and to expand the Strategic National Stockpile. Added provisions support domestic production of certain antibiotics, further study on incentives for domestic production of generic drugs, and programs to enable rapid development and testing of drugs. A new White House Office of Pandemic Preparedness will oversee these efforts.

And vaccine makers and regulators will be following closely a measure setting the stage for an end to government subsidies for vaccines and medical products approved under emergency use authorization policies adopted during the COVID-19 pandemic.

A summary of the Consolidated Appropriations Act, 2023 is available at 

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

Massive Government Spending Bill Tackles Key FDA and Research Issues

Soaring rates of respiratory disease, particularly in children, has ignited demand. This demand has sent consumers searching for a range of usually common prescription and over-the-counter cold remedies and, therefore, angering parents, doctors, and health policy makers. While drug companies are required to inform FDA about manufacturing and supply issues likely to lead to product shortages, industry is not required to communicate changes in demand, leaving the regulators often feeling blind-sided by market changes that affect supply chains before any response can be mounted.

Valerie Jensen, associate director of FDA’s Drug Shortage Staff in the Center for Drug Evaluation and Research (CDER), acknowledged FDA’s limited authority for tracking drug demand spikes during a

 sponsored by The Alliance for a Stronger FDA. Jensen urged manufacturers to report such demand fluctuations, while acknowledging that the agency lacks authority to require such information.

Analysts blame the current scarcity of cold and fever therapies able to provide symptomatic relief on a “triple whammy” of high respiratory virus levels from influenza and respiratory syncytial virus (RSV), as well as ongoing COVID-19 infections. This surge in illness also has boosted demand for amoxicillin and other antibiotics, low-cost generic drugs that usually are widely available. Even though these drugs are not effective against viruses, they can treat the bacterial respiratory infections that often result.

Jensen explained that FDA has had authority since 2012 to require manufacturers to report manufacturing and supply situations likely to limit product supplies. Such information can prompt an agency investigation to determine where there is a supply gap or available substitute products. If the drug is needed to address a critical medical situation, FDA may take steps to facilitate access to alternative ingredients or treatments. Additional options are for FDA to qualify a new raw material supplier, authorize a temporary import, extend expiration dates, or approve stop-gap methods to remove particles from a liquid formulation. Jensen noted that FDA also consults regularly with international regulatory authorities to keep informed on what products may be available for import in an emergency. FDA regularly posts information on 

 and recently added specifics on the supply situation for

The current weaknesses in the drug supply chain have 

prompted leading Senators to call for FDA

 to more forcefully address shortages in amoxicillin and other disease treatments. The situation also continues to drive interest in “buy American” proposals to boost drug production in the United States and reduce dependence on imports to maintain strong supplies. Legislative 

 offer tax incentives for manufacturers to produce antibiotics and other needed drugs for government stockpiles and to have the capacity to meet unexpected demand.

Overall, though, frequent and ongoing supply chain issues for drugs are not unusual, as FDA regularly reports about 100 short supply situations for medicines; FDA’s current list of 123 drug shortages is just above usual levels, Jensen reported in the December 2022 webinar. What concerns her more, though, are “ongoing shortages” that continue from year to year.

Jensen said that alerts from companies of spikes in demand for a product can help address shortages as quickly as possible with fast review and approval of an alternative treatment or permitting continued use of a product while a quality problem is being fixed. For the long run, FDA continues to encourage companies to adopt quality production systems that are more reliable and predictable. And all parties recognize the need for better analytics to identify suppliers with resilient, modern manufacturing systems able to address shortage situations quickly and efficiently.

FDA struggles to track shortages caused by a rise in demand.

Rising Demand Drives Drug Shortages

This past year has been marked by continued efforts to develop, regulate, and distribute important therapies and vaccines to treat lethal and rare diseases, including the still-dangerous COVID-19 virus. Despite generally high praise for biopharmaceutical companies in advancing these efforts, industry was unable to block the adoption of price controls for prescription drugs, a policy that risks limiting research in some areas. At the same time, the tense political environment leading up to the November mid-term Congressional elections blocked agreement on many important legislative and regulatory initiatives for FDA, delaying until the very last moment reauthorization of critical user fee programs to support the agency. Despite the anxiety generated by that cliff hanger, FDA succeeded in maintaining an efficient oversight and approval program for new and important therapies and issued multiple new guidances, renewed field inspections, and launched a range of initiatives to support public health.

The delay in Congress renewing user fees for drugs, biologics, generic drugs, medical devices, and biosimilars hampered FDA planning and put multiple new programs on hold. Uncertainty over future funding made it difficult to attract much-needed new staffers to the agency. And the need to drop from the fee bill a host of legislative proposals put in limbo important measures to strengthen FDA’s accelerated approval process, update regulation of new 

 diagnostics, and enhance FDA’s authority to regulate cosmetics.

At the same time, the Biden administration succeeded in pushing through legislation to limit price increases on certain drugs and to authorize negotiations on leading medicines covered by the Medicare program. While advocates predict that the policy will yield billion-dollar savings in the years ahead and plan to press for curbs on high launch prices, biopharma companies claim it will discourage biotech innovation in areas facing uncertain long-term return on investment. Meanwhile, industry pushed back against expansion of the federal 340B program, which authorizes steep discounts on drugs distributed to certain hospitals and clinics and also joined efforts to question rebate and coverage practices of Pharmacy Benefit Managers (PBMs) that play a key role in how drugs are covered and made available to patients (1).

A preferable strategy for pharma in curtailing drug prices is to achieve more efficient and less costly clinical trials, a goal that has prompted a range of industry and FDA initiatives to modernize biopharma research operations. The pandemic supported wider use of remote and online systems to enroll study participants and oversee treatment and patient status, with digital technologies becoming more widely used for patient monitoring. These approaches also appeared effective in advancing diversity among study participants, where remote site visits may facilitate enrollment of individuals facing difficulties traveling to clinical sites.

The ongoing surge in R&D for cellular and gene therapies prompted a reorganization and expansion of FDA offices overseeing these products and efforts to clarify and update regulatory policies in this area. The importance of FDA providing individualized advice for these cutting-edge therapies highlights the critical need for the agency to attract experts to its staff able to oversee and encourage new methods and innovations.

Continued shortages in both new and long-used drugs and medical products fueled FDA efforts to encourage industry adoption of advanced manufacturing systems and support for regulatory programs designed to ensure production of high-quality treatments on a continual basis. Similarly, the expansion in innovative biotech therapies and vaccines highlighted the importance of modern production methods able to quickly ramp up production of new treatments. FDA continued to advance several initiatives to improve product quality, including proposals for a Quality Management Maturity program for drugs and biologics; appropriate oversight of products with limited chemistry, manufacturing, and controls information due to expedited development treatment; and wider use of smaller, mobile drug production methods, such as distributed and point-of-care manufacturing.

FDA recognized the challenges in overseeing these developments as it moved to revive field inspection operations for manufacturing facilities and bioresearch operations. The agency indicated its intent to continue utilizing alternative remote inspection methods adopted during the pandemic based on the experience of inspection personnel in gaining needed information remotely on the status and compliance of sites, especially those with strong histories of meeting regulatory requirements (2). This shift to a dual inspection mode that incorporates document reviews and online “site visits” with real-time inspections is likely to become a permanent part of the agency’s oversight operations for manufacturers and clinical research operations in the United States and overseas.

This past year was a difficult one for FDA Commissioner Robert Califf, who faced critical questioning and a long delay in gaining Senate confirmation to head the agency again after a brief time as commissioner in 2016. Califf came back to FDA with long experience in advancing the development and oversight of critical new therapies to further combat global pandemics and lethal diseases. However, the commissioner had to spend much time and energy on a host of health crises, including a serious shortage in infant formula, rising death rates from opioid overdoses, and pressure to curb marketing of vaping products and e-cigarettes.

A serious challenge for Califf and health authorities is the continued rise in misinformation about coronavirus medical treatments and vaccines. FDA and other public health agencies struggled to boost COVID-19 vaccination rates and counter anti-vaccine voices, while also combatting the promotion of untested and dangerous “treatments” for COVID and other serious health conditions. This anti-science rhetoric was a major frustration for all involved and will continue to shape public health initiatives and FDA leadership and operations in the months ahead.

340B: The Unintentional Hospital and Pharmacy Profit Stream That Was Supposed to Help Patients

FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health


Vol. 46, No. 12
December 2022
Pages: 14–15

When referring to this article, please cite it as J. Wechsler, “Managing mRNA Instability During Formulation, Manufacturing, and Shipment,” 

Health crises, political tension, and budget concerns were major challenges.

Pandemic and Politics Shaped Pharma and FDA in 2022

While it may take weeks to know the final tally, neither Republicans nor Democrats are expected to have more than a slim majority in the House or Senate, which reduces the likelihood of highly partisan legislation in the months ahead. The economy and inflation were main concerns driving voters to the polls, but they did not generate the predicted ‘Red Wave’ to challenge Biden administration policies. At the same time, access to abortion was a prime issue, with voters supporting abortion rights ballot measures in five states. Even conservative voters opposed major reductions in health care, as seen in the vote in South Dakota to expand Medicaid coverage for low-income adults.

The situation makes it unlikely that Congress will tackle significant legislation during its lame duck session after Thanksgiving. Current members face a Dec. 16, 2022 deadline to approve an omnibus spending bill authorizing the federal government budget for 2023 to avoid a government shutdown. FDA would like the legislators to approve some of the measures dropped from the “slim” user fee reauthorization package approved in late September, but the calendar leaves little time for much debate. There’s a chance for approval of more targeted bills to revise FDA’s accelerated approval process, advance clinical trial diversity, clarify FDA inspection authority, and address cybersecurity in medical devices. But more complex measures to overhaul FDA regulation of 

 diagnostics, cosmetics, and dietary supplements are likely to remain on hold until the new Congress convenes in January.

In the House, a shift to Republican control is most likely, setting the stage for GOP-led committees that will hold hearings and issue reports challenging a range of health care issues. FDA officials are likely to be called to Capitol Hill more often to explain actions related to the shortage in infant formula, difficulties in reducing deaths from opioids, its proposal to ban menthol cigarettes, and modified rules for accessing health care through video conferencing.

The Senate Health, Education, Labor and Pensions (HELP) Committee is expected to have new leadership even if Democrats retain control. Chair Patty Murray of Washington may move to lead the powerful Senate Appropriations Committee, which leaves Bernie Sanders of Vermont as next in seniority. And with ranking Republican Richard Burr (R-N.C.) retiring, Sen. Rand Paul (R-Ky) is in line to head the panel. Sen. Paul already is taking about committee investigations into the Biden administration’s inadequate response to the COVID-19 pandemic, with Anthony Fauci a prime target.

Republican promises to lower taxes and reduce inflation by slimming down federal spending raise uncertainties about support for future pandemic planning, replenishing national stockpiles of drugs and vaccines, expanding research at the National Institutes of Health and strengthening state Medicaid programs. A main target for GOP leaders is the Inflation Reduction Act (IRA), a prime initiative for the Biden Administration that featured a provision reducing consumer outlays for prescription drugs. Although Republicans criticize many aspects of the legislation, they are unlikely to have the votes to kill drug price negotiation authority for Medicare. At the same time, Republican leadership makes further drug pricing legislation unlikely, including proposals to curb pharmaceutical launch prices.

At the same time, Republican leaders are expected to press for changes in FDA policies to make it difficult for women to access approved abortions pills and to gain access to over-the-counter contraception. A main issue is slated to be FDA’s authorization of telemedicine visits for prescribing abortion pills, instead of requiring women to visit the doctor’s office. It also remains to be seen to what extent abortion foes question the right of pregnant women to access approved therapies for cancer and other lethal conditions that also could jeopardize the health of a fetus.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session. 

Major FDA Reform Unlikely in Closely Divided Congress

As expected, Congress reauthorized four key user fee programs at the last moment, as part of a must-pass measure to fund the federal government for another two months. The Continuing Resolution (CR) signed on Sept. 30, 2022 averted a federal government shutdown by extending the October 1, deadline for approving a federal spending plan for fiscal year 2023 to Dec. 16, 2022—after the mid-term elections in hopes that this will enable the legislators to reach a viable budget compromise.

This article was originally published online on October 5, 2022.

The CR reauthorizes fees for drugs (Prescription Drug User Fee Amendments [PDUFA]), generic drugs (Generic Drug User Fee Amendments [GDUFA]), biosimilars (Biosimilar User Fee Amendments [BsUFA]), and medical devices (Medical Device User Fee Amendments [MDUFA]) for the next five years, 2023–2028. In confirming FDA’s authority to collect fees from manufacturers, the agency avoids having to notify thousands of fee-supported staffers of looming layoffs. That prospect already had eroded agency morale and undermined efforts to recruit and hire needed staffers, as FDA struggled for months to maintain and expand its professional workforce during the added hardships imposed by the pandemic and in a very competitive labor market.

Medical product user fees generate some $2 billion in agency revenues, approximately 40% of FDA’s non-tobacco budget. While Congressional leaders on both sides of the aisle support this program to bolster key agency operations and innovations, the broader political debate over escalating government spending generated concerns about new fee-supported initiatives that extend the agency’s authority.

Even so, FDA officials, manufacturers, and research advocates gave a loud sigh of relief following the Congressional action. Commissioner Robert Califf praised the user fee reauthorization measure, while thanking agency staffers for their diligence in engaging in this “prolonged, demanding and, at times, frustrating process.” He noted that the bill avoids “a devastating impact” on FDA’s ability to carry out its “independent and transparent review of medical products.”

Califf added that FDA is committed to working with Congress to enact additional policy changes to benefit public health, but for now, is moving fast to implement multiple new fee-supported policies and programs. Similarly, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), praised the
new fee programs for supporting CDER’s commitment to monitoring the safety of marketed products, protecting patients in clinical trials, and facilitating review of treatments for life-threatening diseases.

In an effort to make up for lost time in meeting tight deadlines for implementing new PDUFA-backed initiatives, FDA quickly posted a new webpage outlining criteria for manufacturers to participate in the new Split Real Time Application Review (STAR) program to accelerate patient access to critical therapies. The pilot aims to shorten the review time for efficacy supplements to approved drugs and biologics through earlier review of certain submissions before clinical study reports are final (1). FDA also provided information on a new Rare Disease Endpoint Advancement (RDEA) pilot to develop novel efficacy endpoints for critical treatments (2). Still to come are multiple new
policies described in the PDUFA VII commitment letter (3).

Enhancements in GDUFA III aim to reduce the number of assessment cycles for generics, support the development and approval of complex generics, and help manufacturers resolve quality issues more quickly. First off the line are new draft guidance documents on assigning review goal dates based on a manufacturing facility’s readiness for inspection (4) and on early assessment of APIs to speed application review (5). There’s new guidance on expediting development of “competitive” generic therapies and on policies for reviewing complex generic products (6). More information on GDUFA III is available on FDA’s website (7).

And for biosimilars, BsUFA III priorities involve expediting the review of certain supplements and launching a new regulatory science program to advance biosimilars and interchangeable products, already posted in a new FDA webpage outlining new pilots to improve the efficiency of biosimilar development and for interchangeable products (8). Further program revisions are listedin the BsUFA commitment letter (9).

The “skinny” user fee reauthorization dropped multiple high-profile proposals for revising how FDA regulates in vitro diagnostics, dietary supplements, and cosmetics, as well as the agency’s accelerated drug approval program and the regulation of artificial intelligence based medical devices. Advocates for developing critical new antibiotics back the PASTEUR Act to establish a new funding mechanism to support the development and proper utilization of drugs to fight resistant diseases. There is bi-partisan support for this “subscription” model for new cures, but its estimated cost of $11 billion over 10 years makes it a hard sell.

In past user fee reauthorization campaigns, a deadline to prevent fee expiration encouraged legislators to slip numerous pet proposals into this must-pass legislation. All parties recognized that this year would be much trickier, with a sharply divided Congress heading into mid-term elections and generally
unwilling to agree on much in the policy arena. This short-term
budget agreement avoids a government shutdown and funding crisis at FDA, but it dims prospects for enacting innovative, controversial or complex new measures.

Split Real Time Application Review (STAR),

 Development Resources, FDA.gov, accessed
Oct. 12, 2022.

Rare Disease Endpoint Advancement Pilot Program, Development Resources, FDA.gov,

PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027.

Facility Readiness: Goal Date Decisions Under GDUFA, Guidance for Industry, Draft Guidance

 Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA, Guidance for Industry, Draft Guidance

Competitive Generic Therapies, Guidance for Industry

FDA, Biosimilars–Science and Research, 

FDA, Biosimilar Biologic Product Reauthorization Performance
Goals and Procedures Fiscal Years 2023 Through 2027, 


Volume 46, Volume 11
November 2022
Pages: 14_15

When referring to this article, please cite it as J. Wechsler, “FDA User Fees Reauthorized,” 

FDA keeps its user fees but fails to gain important reforms.