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Regulatory Focus – This Week at FDA: QSR meeting, Woodcock’s new role, and more

Regulatory Focus – This Week at FDA: QSR meeting, Woodcock’s new role, 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, we learn that FDA is convening its external expert group on medical device GMPs to discuss its plan to align the Quality System Regulation (QSR) with the international standard, ISO 13485:2016. We also look at the some takes on what Robert Califf will face as FDA commissioner this time around.

After years of waiting, we’ll likely get our first look at FDA’s proposal to align the QSR with ISO 13485:2016 in the coming weeks. The long-delayed proposed rule recently made its way through the Office of Management and Budget. On 2 March, FDA’s Device Good Manufacturing Practice Advisory Committee will meet for the first time since 2013 to discuss the agency’s proposal. The meeting materials, and the meeting itself, could offer the first glimpse at the future of the QSR.

Following the news of Califf’s confirmation on Tuesday, we learned that Janet Woodcock will stay on at FDA as principal deputy commissioner, ending speculation about what the former CDER director will do after her time as acting commissioner is up. Several groups offered their congratulations to Califf, including the Friends of Cancer Research, Research!America, and the Alliance for a Stronger FDA. With Califf now headed back to the agency, we take a look at some views on what he’ll be faced with in STATEndpoints and Pink Sheet.

FDA also announced three upcoming meetings and workshops, including its Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop on 9 and 10 May, a public meeting to review the final assessment of the agency’s enhanced review transparency and communication efforts under BsUFA II, plus an advisory committee meetings to review Amylyx Pharmaceuticals’ application for its amyotrophic lateral sclerosis (ALS) drug. You can read more about the leadup to the Amylyx advisory committee at Endpoints.

Drugs & biologics

FDA’s second stab at a draft guidance on verification systems under the Drug Supply Chain Security Act (DSCSA) is up for OMB review. The agency issued the first version of the draft guidance in 2018, but went back to the drawing board after drugmakers took issue with some of the provisions of the guidance.

The agency also retreated on its recent proposal to collect pharmaceutical volume manufacturing data from industry this year. In a brief statement, the agency said the recommended timelines for submitting the reports laid out in its recent draft guidance are not requirements after industry groups said they would not be ready to meet those timelines.

Members of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) this week voted 14-8 against the approval of Avenue Therapeutics’ IV tramadol product. While FDA is not required to follow the advice of its advisory committees, it often does so, and in this case the agency has twice rejected Avenue’s application for the drug.

We also read in Pink Sheet that at least some generic drugmakers see FDA’s recently proposed plan for “PANDA” applications for pre-Hatch-Waxman generic drugs as a bridge too far and might consider withdrawing affected applications.

FDA announced support for version 3.1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standards for Exchange of Nonclinical Data Implementation Guide (SENDIG) as of 15 February. The standard will be required in drug and biologics applications beginning 15 March 2023.

Medical devices

Earlier this week, FDA provided an update on ongoing postmarketing studies for the permanent birth control device Essure, which has been off the market for several years. The interim results are from a second planned interim analysis of patients who completed one year of follow-up in the 522 study. The results showed that a growing number of patients have had their Essure devices removed. The study is ongoing and additional interim results are expected after all patients have completed three years of follow up.

Despite FDA’s challenges conducting inspections in 2021, Medtech Insight reported this week that the agency sent out more quality-related warning letters to device makers last year than it did in any of the last four years.

FDA continued its device classification streak by classifying three types of devices into class II (special controls) this week. Those devices include electromechanical tear simulatorsintegrated continuous glucose monitoring systems, and catheters for the creation of an arteriovenous fistula for hemodialysis access.