This Week at FDA: Spring regulatory agenda, upcoming guidances, and more

This Week at FDAThis Week at FDA
| 24 June 2022 | By Michael Mezher 

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, we get a glimpse at FDA’s Spring regulatory agenda and get tips on several upcoming guidances. Plus, we learn about a new 510(k) pilot program for CBER-regulated medical devices.
 
Next week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss SARS-CoV-2 strain composition for modified COVID-19 vaccines. The much anticipated comes after Moderna and Sanofi/GSK touted positive results for their bivalent COVID-19 vaccines that in part target the Omicron variant earlier this week.
 
This week, the Office of Management and Budget released FDA’s Spring regulatory agenda, detailing the proposed and final rules the agency intends to issue. The Spring agenda contains more than 70 rules that run the gamut of FDA’s regulatory remit.
 
Speaking of agendas, the Center for Biologics Evaluation and Research (CBER) updated its 2022 guidance agenda to note that it plans to finalize guidance on studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial sometime this year.
 
Courtesy of our colleagues at Politico, we learned that the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees are preconferencing on legislation to reauthorize FDA’s user fee programs. The two chambers’ packages contain “significant differences” that must be addressed quickly to allow the legislation to move forward before Congress recesses in August.
 
On the topic of funding, the House Appropriations Committee voted to send its FY2023 spending bill to the House floor for a vote on Thursday. The committee also published a report detailing the issues it wants FDA to tackle with its funding boost. Read more at Endpoints.
 
We also learned this week that FDA might soon release a draft questions and answers guidance on conducting remote regulatory assessments, and two draft guidances related to the Drug Supply Chain Security Act: a revised guidance on identifying trading partners and standards for interoperable exchange of information for tracing certain drugs. The draft guidances reached the Office of Management and Budget for review earlier this week.
 
Drugs & biologics
 
Reuters reported on the results of a US Centers for Disease Control and Prevention study that found that COVID-19 antivirals made by Merck and Pfizer were half as likely to be given to people who live “socially and economically disadvantaged regions.”
 
If anyone is thinking about starting a new interest group (IG) within CDER’s Office of Biostatistics, this new Manual of Policies and Procedures (MAPP) will be of interest. The MAPP explains that “an IG is a group of OB staff members with a common interest in a particular topic. The topic can be scientific, social, or procedural,” and are distinct from working groups and committees defined in another MAPP.
 
FDA’s Office of Tissues and Advanced Therapies (OTAT), which has been inundated with submissions in recent years, has posted a new guide explaining how to interact with the office at various stages of development that applicants may find useful.
 
Medical devices
 
CBER, which also regulates some medical devices, is standing up its own voluntary 510(k) electronic submission template and resource (eSTAR) pilot program, similar to the one operated by the Center for Devices and Radiological Health (CDRH). The center is seeking up to nine volunteers to participate in the pilot program.
 
After concerns were renewed about the accuracy of pulse oximeters for individuals with darker skin during the COVID-19 pandemic, FDA this week announced it will convene its Medical Devices Advisory Committee to review the available data and make any necessary regulatory recommendations for the devices.
 
FDA also classified several medical device recalls as Class I recalls, including recalls affecting Draeger’s SafeStar 55 breathing system filters, Medtronic’s HeartWare HVAD system batteries and Baxter’s Volara System.

 

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