FDA Policy/General

Information Collections Approved by OMB

Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are:

Experimental Study of an Accelerated Approval Disclosure
Interstate Shellfish Dealer’s Certificate
Administrative Detention and Banned Medical Devices
Medical Device User Fee Small Business Qualifications and Certifications
Individual Patient Expanded Access Applications
Electronic Forma for Submissions; Promotional labeling and Advertising Materials for Human Prescription Drugs
Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Electronic Submission of Medical Device Registration and Listing
Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Read more

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