This Week at FDA: FDA signs new GMP MRA, Health Canada eSTAR pilot, and more

This Week at FDAThis Week at FDA | 13 January 2023 |  By 

Editor's note: This article has been updated to correct a link to the Federal Register.

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 two developments that could promote international regulatory harmonization and ease some burdens for regulated industry.
 
On Thursday, FDA said it had signed a mutual recognition agreement with Switzerland that would enable the two countries to recognize good manufacturing practice inspections of human and veterinary pharmaceutical manufacturers, which could eliminate some “duplicate inspections.” FDA notes that it has similar agreements in place with the European Union and the United Kingdom.

“Once the MRA enters into force, the FDA will be able to rely on the factual findings of Swissmedic experts in many cases, thus avoiding duplicate inspections and allowing the FDA to expand its inspectional reach,” said Andi Lipstein Fristedt, FDA Deputy Commissioner for Policy, Legislation and International Affairs, who signed the MRA on FDA’s behalf.
 
The agency also announced the launch of an eSTAR pilot program with Health Canada on Tuesday. Under the pilot, participants will be able to submit a single eSTAR to both FDA and Health Canada. The agencies are looking for nine participants to join the pilot who can submit an eSTAR to both jurisdictions for a medical device within six months of the pilot.
 
FDA Commissioner Robert Califf appeared in the news multiple times this week following his appearance at the JP Morgan Healthcare Conference in San Francisco. He also participated in a roundtable discussion hosted by the White House Office of Science and Technology Policy (OSTP) on clinical trial infrastructure on Thursday.
 
According to Endpoints, the FDA Commissioner called for more drugmakers to conduct clinical trials in the US. Califf also gave his thoughts on GSK’s recent move to withdraw its accelerated approval for its multiple myeloma drug Blenrep (belantamab mafodotin-blmf) within weeks of FDA’s request. Fierce reports that Califf said the decision demonstrated “a great sign of corporate responsibility,” not noted that drugmakers shouldn’t necessarily pull products from the market immediately after a confirmatory trial failure.
 
Plus, we saw Rep. Earl Carter (R-GA) and 24 of his Republican colleagues write to Califf to criticize the agency’s recent move to allow mifepristone to be dispensed by certified pharmacies, which would enable retail pharmacies to dispense the pill for the first time.
 
Drugs and biologics
 
CBER Director Peter Marks wrote in JAMA about the “urgent need” for new approaches for developing future COVID-19 vaccines. Marks called the latest bivalent boosters “a temporizing measure until variants emerge that necessitate additional booster vaccination or modification of the current generation of vaccines” and stressed that “an attempt to produce vaccines that lead to broad long-lasting immunity is clearly needed.”
 
In a new CDER Conversations post, Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars within the Office of New Drugs, and Steven Kozlowski, director of the Office of Biotechnology Products within the Office of Pharmaceutical Quality, discuss the agency’s plans to implement the Biosimilar User Fee Amendments (BsUFA III) program and its new biosimilars regulatory science program.
 
We also read this post from Claudia Manzo, director of the Office of Medication Error Prevention and Risk Management within CDER’s Office of Surveillance and Epidemiology on implementation challenges and opportunities for risk evaluation and mitigation strategies.
 
This week, we a second look at FDA’s generic drug metrics for FY 2023 with the release of the agency’s monthly activity data for November 2022. In November, FDA approved 60 abbreviated new drug applications (ANDAs) and tentatively approved another 13 applications.
 
FDA also updated its data on regenerative medicine advanced therapy (RMAT) designations to include the first quarter of FY 2023. The agency received 7 requests for designation during the most recent quarter and denied two requests. No requests were granted or withdrawn during that time.
 
The agency approved AstraZeneca’s new combination asthma inhaler for adults this week. According to FDA, the Airsupra (albuterol and budesonide) inhaler is “the first combination of an inhaled corticosteroid (ICS) and a short-acting-beta-agonist to be approved in the US [and] the first product containing an ICS to be approved in the US as a reliever treatment (rather than as a controller) for asthma.”
 
Medical devices
 
FDA issued classification orders for two medical devices, digital therapy device to reduce sleep disturbance for psychiatric conditions and prognostic test for assessment of liver related disease progression. Both devices were placed into class II (special controls) follow de novo requests that were first made in 2020.
 
FDA is planning to host a webinar on electromagnetic compatibility (EMC) of in vitro diagnostic devices on 2 February 2023.

 

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