FDA Policy/General

Latest Federal Register Notices

Regulatory Review Period Determined for Dojolvi
12/2/2021 Federal Register news: FDA has determined for patent extension purposes the regulatory review period for Ultragenyx’s Dojolvi (triheptanoin), indicated as a source of calories and fatty acids for treating pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders. The review period is 2,511 days, which includes 2,175 days that occurred during the testing phase and 336 days during the approval phase. To view the notice, click here.

Info Collection: Antimicrobial Distribution Reporting
12/1/2021 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Antimicrobial Animal Drug Distribution Reports and Recordkeeping — 21 CFR 514.87” (OMB Control Number 0910-0659). Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required to submit to FDA an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. Sponsors are also required to maintain distribution records for their animal drug products. To view the notice, click here.

Product-specific Draft Bioquivalence Guides
12/1/2021 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.

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