Drugs

OGD Approved 100 ‘Competitive’ ANDAs in 2021

CDER’s Office of Generic Drugs says it reached a milestone last year when it approved 100-designated “Competitive Generic Therapy (CGT)” ANDAs. The CGT pathway for generic drugs helps incentivize the entry of drugs with “inadequate generic competition” to the market. “This milestone is a sign the program is achieving its goal – the development and market availability of safe, effective generic drugs in areas of the market that previously had little to no competition,” it says.

“Scientific and regulatory collaborations helped us create new approaches to support timely assessment and approval of many generic drug products in 2021,” OGD says in its just-released annual report. “The FDA, in partnership with the University of Maryland and the University of Michigan (the Center for Research on Complex Generics), collaborated to reach thousands of stakeholders worldwide with workshops that stimulated dialogue and generated knowledge about science and innovative research crucial for the development of complex generic medicines... Globally, our collaborative work included the launch of a joint FDA and European Medicines Agency pilot program to provide parallel scientific advice to developers of complex generic drug products. The pilot program allows assessors from the two agencies to concurrently communicate their views on scientific issues, in real time, to manufacturers working to develop complex generic drugs.”

The annual report notes that 2021 saw 776 approved or tentatively approved ANDAs. It says that 108 pre-ANDA meeting requests were acted on regarding product development or pre-submission issues. Other notable accomplishments:

149 product-specific guidances (PSG) for industry and other stakeholders were issued, including 88 new draft PSGs, and 61 revised draft PSGs.
3,901 controlled correspondence inquiries received from industry.
1,787 complete response letters were issued detailing the deficiencies applicants needed to resolve before FDA could grant approval.
$20 million in funding provided to a variety of researchers for generic drug science and research programs.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome