This Week at FDA: Remote regulatory assessments guidance, 12-digit NDCs, 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 released its long-awaited guidance on how it plans to incorporate remote regulatory assessments across product areas going forward. The agency also issued a proposed rule to adopt a uniform 12-digit format for national drug codes (NDCs) and updated its list of medical devices in shortage.The biggest news of the day is that FDA released its critical draft guidance detailing how the agency plans to incorporate its remote regulatory assessments across all regulated products beyond the COVID-19 pandemic. Read more of our coverage of the guidance here.
Earlier today, FDA released a proposed rule announcing its intent to adopt a “single, uniform 12-digit format” for FDA-assigned NDCs. The agency will soon run out of the current 10-digit NDCs, so the switch to 12-digit codes is meant to avoid disruption by offering a set date for the transition to the new, longer codes.
Additionally, FDA released final guidance explaining what happens if generic drug sponsors fail to respond to complete response letters within the regulatory timeframe, as well as a final questions and answers guidance on the Orange Book. FDA also issued draft guidance offering insights on its Real-Time Oncology Review (RTOR) program. More to come on those guidances next week.
After drawing criticism for not moving more quickly to inspect Bavarian Nordic’s Denmark facility where it makes its monkeypox vaccine Jynneos, FDA Commissioner Robert Califf tweeted that the agency is “finishing up important work to ensure the quality of the monkeypox vaccine doses coming to the U.S.,” noting that the work goes beyond just filing paperwork.
The agency also offered advice on proper sample collection when testing for monkeypox to reduce the risk of false results.
While unrelated to medical products, Califf announced that the agency has commissioned an external review of its human foods and tobacco programs after several high-profile controversies that have raised questions about the agency’s ability to effectively oversee the products under those programs’ purviews.
Drugs & biologics
Plus, we’re reading in Endpoints that FDA inspections of biosimilar facilities have lagged behind those for drugs and generics, according to Juliana Reed, executive director of the Biosimilars Forum.
FDA also released its latest quarterly activity report for its generic drugs program, detailing its performance on abbreviated new drug applications through June 2022. It also provided a quarterly update on priority and competitive generic therapies.
We’re also reading this warning letter sent to Carlsbad, CA-based Imprimis Rx over the company’s promotional materials related to its compounded eye drop product Pred-Moxi-Brom (prednisolone acetate 1%, moxifloxacin 0.5%, and bromfenac 0.075%). The agency previously warned the company over promotional materials for other prescription eye drop products in 2017.
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni announced that Marta Sokolowska will step into a newly created position within the center as the deputy center director for substance use and behavioral health.
“At a time of the growing drug overdose crisis in the U.S., Marta will be the center’s executive-level leader responsible for strengthening and advancing our public health response to the non-medical use of substances with abuse potential. These efforts include minimizing risks associated with problematic use, while enabling appropriate access for medical use,” Cavazzoni said. Sokolowska will continue in her roll overseeing CDER’s Controlled Substances Program (CSP).
Medical devices
Earlier this week, the Center for Devices and Radiological Health (CDRH) announced that it is “developing a new way for industry to electronically upload CDRH-led premarket medical device submission files in the eSTAR (510(k) and De Novo) and eCopy formats.” The agency said that existing users of its Customer Collaboration Portal’s progress tracker can now test the process and offer the agency feedback on it.
Nearly 50 industry organizations wrote to the leaders of the House Energy and Commerce and Senate Health, Education, Labor and Pensions committees to urge the committees to include the VALID Act as part of the FDA user fee reauthorization package. The VALID Act is attached to the Senate Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 but was not included in the House version of the bill.
FDA also updated its medical device shortage list to include automated external defibrillators (AEDs) and chest drains and to remove from the list medical gowns and surgical masks, Medtech Dive reports.
