FDA Policy/General

Federal Register Notices: Week Ending 1/1/2021

The follow are the Federal Register notices published the week ending 1/01/2021:

Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/28/2022. To view the notice, click here.

Federal Register notice: FDA has made available a final guidance entitled Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling. The document describes how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies documents beginning 12/28/22. To view the notice, click here.

Federal Register notice: FDA has announced a 1/27 public meeting entitled “Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA).” Topics to be discussed are the interim assessment and public stakeholder views about the program to date. To view the notice, click here.

Federal Register notice: FDA has announced a 2/9 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Merck sBLA for Keytruda (pembrolizumab) for treating patients with high-risk, early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery. To view the notice, click here.

Federal Register notice: FDA has announced the user fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year 2021. The agency last year was given authority to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. To view the notice, click here.

Federal Register notice: FDA has made available a final guidance entitled Product Labeling for Laparoscopic Power Morcellators.’ The document updates recommended Contraindications and Warnings information to be included in product labeling to reflect the state of the science and available technology about using laparoscopic power morcellators. To view the notice, click here.

Federal Register notice: FDA has made available a final guidance entitled Consumer Antiseptic Rub Final Rule Questions and Answers. 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