FDA Policy/General

Latest Federal Register Notices

7 No-Longer-Marketed ANDAs Withdrawn
03/25/2021 Federal Register notice: FDA is withdrawing approval of seven ANDAs from multiple applicants after they notified the agency that the drug products are no longer marketed and requested that they be withdrawn. To view the notice, click here.

Info Collection on DTC Study on Indications
03/25/2021 Federal Register notice: FDA has submitted to OMB an information collection entitled “Study of Multiple Indications in Direct-to-Consumer Television Advertisements.” The study will provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television advertisement. It will also explore whether similarity of the indications affects participants’ likelihood to recall and understand the indications, and whether its effect would be positive or negative. To view the notice, click here.

No ANDAs Allowed for Withdrawn Belviq: FDA
03/25/2021 Federal Register notice: FDA has determined that Eisai’s Belviq and Belviq XR (lorcaserin hydrochloride) tablets were withdrawn from sale for reasons of safety or effectiveness. The determination will prevent any ANDA from being approved that references either product. The drugs are indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults. In 2012, the agency required a placebo-controlled clinical trial to evaluate the risk of cardiovascular problems. A subsequent analysis of the trial results suggested an imbalance in cancer in humans. A drug safety communication was issued 1/2020 and FDA requested Eisai to withdraw the drugs from the market 2/2020. To view the notice, click here.

Device GMP Panel Non-Voting Rep Needed
03/24/2021 Federal Register notice: FDA is seeking industry organizations interested in participating in the selection of a nonvoting industry representative to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee. For those interested, a letter stating that interest should be sent to FDA by 4/5. 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