FDA Policy/General

Latest Federal Register Notices

Public Meeting on Generic Drug User Fees
1/7/2022 Federal Register notice: FDA has announced an 2/16 public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027. To view the notice, click here.

4 Information Collections Approved by OMB
1/6/2022 Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are:

Infant Formula Requirements
Shortages Data Collection
Guidance on Labeling for Natural Rubber Latex Condoms
Section 513(g) Requests for Information

To view the notice, click here.

Enzyvant Wins Priority Review Voucher
1/6/2022 Federal Register notice: FDA has issued a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified rare pediatric disease product application. The agency determined that the company’s Rethymic (allogeneic processed thymus tissue-agdc), indicated for immune reconstitution in pediatric patients with congenital athymia, meets the criteria for a priority review voucher. To view the notice, click here.

Panel to Review Merck Covid Drug
1/5/2022 Federal Register notice: FDA has announced an 1/30 Antimicrobial Drugs Advisory Committee meeting to review a Merck Emergency Use Authorization request for molnupiravir oral capsules, indicated for treating mild to moderate Covid-19 in adults who are at risk for progressing to severe disease or hospitalization. To view the notice, click here.

CDRH Guidance Document Plans for FY 2022
1/4/2022 Federal Register notice: FDA is announcing the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal year 2022. In addition, FDA has established a docket where interested persons may comment on topic priorities. 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