FDA Policy/General

Latest Federal Register Notices

Guide on Premenopausal Women with Breast Cancer
6/17/2021 Federal Register notice: FDA has made available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs for Treatment. The document provides recommendations about including premenopausal women in breast cancer clinical trials. To view the notice, click here.

Progressive Multifocal Leukoencephalopathy Trials Workshop
6/17/2021 Federal Register notice: FDA has announced a 9/21 public workshop entitled “Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs.” The workshop is intended to discuss the challenges and clinical trial design considerations for developing therapeutic products for treating progressive multifocal leukoencephalopathy. To view the notice, click here.

Notice Correction on ANDA Approval Withdrawal
6/15/2021 Federal Register notice: FDA is correcting a 5/12 notice about the withdrawal of approval of 12 ANDAs from multiple applicants. That notice indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the notice was published with an incorrect application number for the product. This notice corrects that error. To view the notice, click here.

Panel Meeting to Review TransMedics PMA
06/14/2021 Federal Register notice: FDA has announced a 7/14 meeting of its Medical Devices Advisory Committee’s Gastroenterology and Urology Devices Panel. The committee is scheduled to discuss, make recommendations, and vote on information on a TransMedics PMA for the Organ Care Liver System, indicated for the resuscitation, preservation, and assessment of liver allografts from donors after brain death or liver allografts from donors after circulatory death. To view the notice, click here.

Notice Corrected on Bravecto Review Period
06/14/2021 Federal Register notice correction: FDA is correcting a 2/12/2018 Federal Register notice to revise the regulatory review period for Merck’s Bravecto (fluralaner), indicated for flea and tick prevention in dogs and cats. The notice is corrected as follows: FDA has determined that the applicable regulatory review period for Bravecto is 1,054 days. Of this time, 1,016 days occurred during the testing phase and 38 days occurred during the approval phase. Based on the correction, it appears Bravecto could be eligible for an additional 37 days of patent protection. 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