FDA Policy/General

Latest Federal Register Notices

Pepcid Not Withdrawn Due to Safety/Efficacy: FDA
1/14/2022 Federal Register notice: FDA has determined that Valeant Pharmaceuticals’ Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. Pepcid is indicated in adult and pediatric patients for treating active duodenal ulcer, active gastric ulcer, symptomatic nonerosive gastroesophageal reflux disease, and erosive esophagitis. The determination will allow FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. To view the notice, click here.

Class 2 for OTC Electrocardiograph Software
1/14/2022 Federal Register notice: FDA is classifying electrocardiograph software for over-the-counter use into medical device Class 2 (special controls). The action is based on an Apple Inc. request for de novo classification of its ECG App. The device is identified as one that creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiacarrhythmias. The agency notes that the device is not intended to provide a diagnosis. To view the notice, click here.

Public Hearing on Carbadox Carcinogenic Concern
1/13/2022 Federal Register notice: FDA is announcing a 3/10 virtual public hearing on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox, a carcinogenic new animal drug used in swine feed. To view the notice, click here.

Final Rule Revokes Older Human Tissue Regs
1/12/2022 Federal Register notice: FDA is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to 5/25/2005. The revocation does not affect regulations for human cells, tissues, and cellular and tissue-based products recovered on or after May 25,2005. The rule is being finalized because the regulations are obsolete or no longer necessary to achieve public health goals. To view the notice, click here.

Draft Guide on Device Discontinuance/Interruption
1/11/2022 Federal Register notice: FDA has made available a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. The agency requires device manufacturers to notify it about a permanent discontinuance or an interruption in a device’s manufacture. 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