FDA Policy/General

10 Info Collections Approved by OMB

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

Export of Medical Devices; Foreign Letters of Approval
Registration of Food Facilities
Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
Medical Device User Fee Cover Sheet—Form FDA 3601
Bar Code Label Requirement for Human Drug Products and Biological Products
Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
Guidance: Emergency Use Authorization of Medical Products and Related Authorities
Production, Storage, and Transportation of Shell Eggs (preventing Salmonella Enteritidis (SE))
Center for Devices and Radiological Health Appeals Processes
Food Labeling: Nutrition Facts Label and Supplement Facts Labels

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