FDA Policy/General

Latest Federal Register Notices

Info Collection Revision on Drug Reporting
12/10/2021 Federal Register notice: FDA has submitted to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products” (OMB Control Number 0910-0230). The collection supports statutory provisions regarding the monitoring of FDA-regulated products. The guidance was revised to provide recommendations for recordkeeping applicable to any pandemic, not just influenza, including recommendations for planning, notification, and documentation for continuity of operations for firms that report postmarketing adverse events during any pandemic. To view the notice, click here.

Guide on Device Software Submissions
12/09/2021 Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Device Software Functions. The document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for the agency to evaluate device software functions. To view the notice, click here.

Adakveo Regulatory Review Period Determined
12/09/2021 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Adakveo (crizanlizumab-tmca), indicated to reduce the frequency of vaso-occlusive crises in adults and pediatric patients with sickle cell disease. The review period is 3,152 days, which includes 2,968 days that occurred during the testing phase and 184 days during the approval phase. To view the notice, click here.

Dengvaxia Regulatory Review Period Determined
12/08/2021 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Sanofi’s Dengvaxia (dengue tetravalent vaccine, live), indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. The review period is 5,710 days, which includes 5,466 days that occurred during the testing phase and 244 days during the approval phase. To view the notice, click here.

Draft Guide on Drug Reporting to FDA
12/07/2021 Federal Register notice: FDA has made available a draft guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act. The document addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. 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