This week at FDA: ANDA prioritization pilot; CDRH guidance priorities, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, FDA announced a new pilot to prioritize generic drug reviews, and the agency’s device center unveiled its proposed guidance priorities for FY 2026.

The major story this week is the ongoing government shutdown, which began early Wednesday as a result of Congress’s failure to reach agreement on a bill to fund the government. According to NBC News, the government shutdown is expected to continue at least until next week, with no resolution in sight. The Senate will not hold any more votes until Monday, and the House has canceled all votes for next week and is not planning to return to Washington until 14 October.

FDA on Friday announced a new abbreviated new drug application (ANDA) prioritization pilot to support US drug manufacturing and testing for generic drug manufacturers. The pilot complements the FDA’s PreCheck program for new drug applications. Under this initiative, ANDA applicants who conduct bioequivalence testing in the US and whose products are made using domestic sources for APIs are eligible for priority review. Applicants can request this priority review by following the procedures outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3 on priority review.

The Center for Devices and Radiological Health (CDRH) has released its proposed list of guidances it plans to issue for fiscal year 2026. Some of the center's key priorities include publishing three final guidances covering the validation of diagnostic tests for emerging pathogens, utilizing real-world evidence to support regulatory decision-making, and developing predetermined change control plans for medical devices.

In other news, Public Citizen has submitted a citizen petition under the Freedom of Information Act (FOIA) to the Department of Health and Human Services (HHS), requesting a copy of the recently announced agreement between Pfizer and the US government aimed at lowering drug costs for patients in the US. The petition follows an announcement made by President Trump and Pfizer CEO Albert Bourla on Tuesday regarding a deal on drug prices that aligns with Trump’s 'most favored nation' campaign. The White House did not release the text of the agreement, which Pfizer claims is confidential.

Drugs

On Tuesday, the FDA published the ICH E20 draft guidance on adaptive designs for clinical trials for comment. This guideline outlines the principles for planning, conducting, and interpreting clinical trials that use an adaptive design, which aims to confirm the efficacy of a treatment and support its benefit-risk assessment.

FDA recently sent two guidances to the Office of Management and Budget (OMB) for review on safety reporting requirements for sponsors of investigational new drug applications (INDs) and bioavailability and bioequivalence studies, as well as safety reporting responsibilities for investigators studying investigational drugs and medical devices.

NBC News reported that FDA has quietly approved Evita Solutions’ generic version of the abortion drug mifepristone, marking it as the second generic version of the drug to be approved since GenBioPro's version was authorized in 2019.

STAT reported that George Tidmarsh, the director of the Center for Drug Evaluation and Research (CDER), expressed concerns about the safety of voclosporin on his personal LinkedIn page. Voclosporin was approved in 2021 to treat lupus nephritis, an autoimmune disease that damages the kidneys. STAT noted that it is “highly unusual” for an FDA official to use a personal social media account to express these concerns without providing evidence to support the claim.

In an FDA Voices post, the agency detailed its efforts to reduce and minimize animal testing for sunscreens. One of these actions includes not requiring animal testing for individual sunscreen products marketed under the sunscreen monograph.

On Thursday, the FDA released its latest batch of product-specific guidances (PSGs) aimed at promoting the development of generic drugs for complex dosage forms. This update includes 17 new guidances and 58 revised guidances, which offer specific recommendations on the design of bioequivalence (BE) studies to support generic drug applications.

FDA issued a warning letter to clinical investigator Pamela Den Beston regarding objectionable conditions found during a clinical trial evaluating the effectiveness of Livionex in reducing plaque and gingivitis in children undergoing hematopoietic stem cell transplantation. One of the key findings was the failure to have an Investigational New Drug (IND) application in effect prior to initiating the investigation.

The agency also published three form 483s handed to manufacturers for various GMP issued stemming from inspections in 2024 and 2025. In a 483 given to Dr. Reddy's Laboratories, Ltd., a biologics manufacturer based in Telangana, India, FDA listed five observations, including some related to insufficient procedures to prevent microbial contamination, after an inspection in September 2025.

Another 483 was given to Laboratorios Grifols, S.A. in Barcelona, Spain, due to inadequate written procedures, insufficient batch control records, and inadequate cleaning validation, following an inspection in July 2024. Additionally, the agency published a 483 it handed to the Serum Institute in Pune, India, listing observations related to its manufacture of COVID-19 vaccines following an inspection in June and July 2024.

Devices:

CDRH released a paper for public comment that addresses various questions regarding the measurement and evaluation of the performance of AI-enabled medical devices in real-world settings. This includes plans for identifying and managing performance drift, such as detecting changes in inputs and outputs.

FDA has announced an expansion of its Early Alert communications pilot after declaring the program a success. This expansion will impact potentially high-risk removals or corrections for all medical devices.

AdvaMed published a technical performance and safety bulletin titled "Remote Device Operations: Common Challenges and Mitigation Strategies" to assist healthcare providers and IT teams in managing remote medical devices and navigating the complex landscape of remotely administering these devices.

This week at FDA: ANDA prioritization pilot; CDRH guidance priorities, and more

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