This Week at FDA: New proposed rules, Biocon's Form 483, and more

Regulatory NewsRegulatory News | 05 November 2021 |  By 

We're trying something new at Regulatory Focus, with the goal of gathering the week’s news from (and about) FDA. We'll be covering agency activities and enforcement actions, filings in the Federal Register, new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop-shop for FDA updates.

What do you think? We’d be happy to hear your feedback at

News from this week

One of the week’s biggest pieces of news was the release of the Generic Drug User Fee Amendments (GDUFA III) commitment letter. You can read more about that here. FDA also announced it will hold a public meeting to discuss the proposed program on 16 November 2021.

A proposed rule on national standards for the licensure of wholesale drug distributors and third-party logistics providers is currently under review at the Office of Management and Budget. The rule is required under the Drug Supply Chain Security Act (DSCSA) but has been delayed for several years past the statutory deadline for its issuance.

FDA has issued final guidance for manufacturers of blood components using a specific pathogen reduction device, Cerus Corporation's Intercept Blood System for Platelets and Plasma. The questions and answers guidance offers recommendations on the implementation of the device, as well as on reporting manufacturing changes related to the device.

Among other new guidances issued this week is a draft guidance on software as a medical device (SaMD) and software in a medical device (SiMD) in premarket submissions and on reporting drug manufacturing volume data to the agency as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Read Regulatory Focus’ coverage of those guidances here and here. In addition to offering guidance on manufacturing volume reporting, FDA also proposed to exempt two categories of biological products – blood and blood components and cell and gene therapy products where one lot treats a single patient – from the reporting requirements.

FDA also announced last week it is investigating certain imported medical gloves that may have been "reprocessed, cleaned or recycled and sold as new." The agency has placed gloves from dozens of companies on Import Alert and has warned health care providers not to purchase or use gloves from any of the listed companies.

The Congressional Research Service (CRS) released a report on FY2022 appropriations for agriculture and related agencies, which includes the FDA.

Enforcement and recalls

FDA released Form 483s from several outsourcing facilities and pharmacies following inspections earlier this year. The agency also released the 483 from its inspection of Biocon's Johor, Malaysia, facility in September.

FDA announced two Class I medical device recalls last week for Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to risk of battery failure and for Zimmer Biomet's ROSA One 3.1 Brain Application due to a software error.

From the journals:

CBER Director Peter Marks took to Nature Medicine about the need to translate lessons learned from the COVID-19 pandemic to enhance regulatory processes going forward. "Choosing wisely to retain the most meaningful regulatory processes will be important to best meet the needs of industry and regulators, while maximally benefiting the public health," he wrote.
The relationship between Medicaid spending and the use of drugs that have received accelerated approval from FDA – mostly oncology drugs – was explored recently by Rachel Sachs and her coauthors in JAMA Health Forum. Sachs, on faculty at Washington University’s law school in St. Louis, found that though drugs that received approval through the accelerated pathway accounted for less than 1% of drug use under Medicaid from 1992 through 2020. However, annual net spending on these drugs added up to as much as 9.1% of the Medicaid drug budget.
A review from Yale’s Jeremy Puthumana and colleagues in BMJ Evidence-Based Medicine looks at the five gene therapies approved thus far. The Yale team examines FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, safety signals, cost issues, and casts an eye forward to RMAT-eligible therapies in development, whose number now approaches 1,000.
“FDA needs a competitiveness czar,” says Peter Pitts, president of the Center for Medicine in the Public Interest in a recent Health Affairs blog post. Pitt, himself a former FDA associate commissioner for external relations, proposes developing a competitiveness scoring system, with additional agency resources and expedited review being offered to high-scoring therapies.
What we're reading

The BMJ reports on allegations of data integrity issues at a contract research organization (CRO) in Texas that was involved in testing Pfizer and BioNTech's COVID-19 vaccine.

FDA's Psychopharmacologic Drugs Advisory Committee voted 12-1 against Levo Therapeutics' nasal spray to treat Prader-Willi syndrome, raising concerns about mixed efficacy evidence from a Phase 3 trial, Endpoints reports.

The New York Times reports that the federal government has cancelled a $600 million contract with Emergent BioSolutions in the wake of manufacturing issues that plagued the facility. (RELATED: FDA finds mess of sterility problems at Emergent, Regulatory Focus 21 April 2021)


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you