This Week at FDA: FDA guidances keep coming, new device harmonization plan, 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 again continued its flood of end-of-year guidances, the agency’s device center published a global harmonization plan, and Novo Nordisk had a particularly tough week.

It’s been another busy week for the US Food and Drug Administration (FDA) as it continued to publish a tranche of guidances, including guidances on how agency staff may use alternative tools to inspect drug manufacturing facilities and conduct formal meetings with drug sponsors. The agency also published guidances covering topics such as prescription drug use-related software, biosimilar labeling, and clinical trials.

In a request for information (RFI), FDA wants to hear from stakeholders about the challenges and opportunities they face when developing individualized cell and gene therapies. The agency wants to hear about issues such as manufacturing, nonclinical development, clinical development, and toxicology.

FDA said its Office of Women's Health and Office of Clinical Pharmacology will hold a virtual workshop on 11 October to discuss the potential impact menopause may have on the pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response to drugs and biologics currently on the market. Presenters are expected to talk about issues such as how menopause may affect drug absorption, distribution, and metabolism and identify potential areas for further research.

Bloomberg Law reports that a Massachusetts district court judge has ordered Pfizer and BioNTech to hand over key information to Moderna about what it learned about the rival's COVID-19 mRNA vaccine formulation in a patent infringement lawsuit. Both sides in the case claim to have independently developed the vaccine technology.

Agency IQ reported that the Center for Biologics Evaluation and Research has updated its standard operating procedures on how it oversees Regenerative Medicine Advanced Therapy (RMAT) products. The new policies update the center's processes for handling requests for designation and how staff interact with sponsors. The center also published an updated standard operating procedure detailing how it will schedule meetings with industry trade groups and document them.

Fierce Pharma reported that according to a Gallup poll, the American public's perception of the pharmaceutical industry is at its lowest so far this century, especially when asking Republican voters. While opinion of the industry had gone up during the pandemic, it has since faded, and now, 60% of Americans view the drug industry negatively.

Drugs & Biologics

Recent reports that Novo Nordisk received a Form 483 from FDA after inspectors found quality control issues in July at its Clayton, NC, manufacturing plant led to a drop in the company's stocks at the start of the week. Following that news, Reuters reported that the problems aren't new and go back to early May last year based on a Freedom of Information Act (FOIA) request.

ARS Pharmaceuticals said this week it had received a Complete Response Letter (CRL) from FDA for its allergic reaction drug neffy (epinephrine nasal spray). The agency has asked for additional data from a pharmacokinetic/pharmacodynamic study, but the drugmaker says it plans to submit a Formal Dispute Resolution Request (FDRR) to dispute the agency's letter.

BioSpace reported that FDA has accepted Orchard Therapeutics’ Biologics License Application (BLA) for its metachromatic leukodystrophy gene therapy treatment OTL-200. It is already approved for the rare disease in Europe, and the US regulatory agency has granted it Priority Review designation.

BioSpace also reported that FDA has accepted Alvotech’s Biologics License Application (BLA) for AVT02, a monoclonal antibody biosimilar that is being proposed as a biosimilar for AbbVie’s Humira (adalimumab). The company initially received a CRL in June after the agency said it had certain deficiencies at its Reykjavik, Iceland, manufacturing facility.

FDA said it is changing the therapeutic equivalence rating for tacrolimus oral capsule products made by Accord Healthcare. The generic drugs are meant to prevent organ rejection in patients receiving kidney, heart, and liver transplants. The agency was concerned about increased risk for toxicity compared to the brand name drug but said new data hadn’t shown any increased risk.

Medtech

The Center for Devices and Radiological Health (CDRH) published a draft document outlining how it plans to achieve regulatory harmonization with other regulatory agencies. The agency noted that the plan builds on work it has already done with international regulators and presents strategies to encourage more harmonization.

On 19 September, FDA announced its Accreditation Scheme for Conformity Assessment (ASCA), which asks sponsors to use FDA-recognized voluntary consensus standards in premarket submissions, is now officially a permanent program after being evaluated under a pilot program. The move is part of the agency's Medical Device User Fee Amendments (MDUFA V) deal commitments.

Medtech Dive reported on a Government Accountability Office (GAO) report that found that resource limitations are preventing FDA and the Federal Trade Commission from more actively going after entities who are illegally advertising medical devices directly to consumers. Due to the limited resources, the report noted that FDA has to use a cost-benefit analysis to decide when to use its enforcement authority.

This Week at FDA: FDA guidances keep coming, new device harmonization plan, and more

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