FDA Policy/General

Latest Federal Register Notices

Consumer Organizations Sought for Advisory Panel Selections
Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels. 09/18/2020

Info Collection on Social Behavioral Sciences Data
Federal Register notice: FDA seeks comments on a new information collection for data to support cross-center collaboration for social behavioral sciences associated with disease prevention and treatment. 09/18/2020

New Study on Disclosures in Drug Ads
Federal Register notice: FDA seeks comments on a new information collection entitled “Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials.” 09/17/2020

Stakeholder Participation for Drug User Fee Reauthorization
Federal Register notice: FDA seeks patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts to participate in periodic consultation meetings on reauthorizing the Prescription Drug User Fee Act. 09/17/2020

Info Collection on Opioid Abuse Deterrent Formulations
Federal Register notice: FDA sends to OMB a new information collection entitled “Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations (ADF).” 09/16/2020

Study of Multiple Indications in DTC Ads
Federal Register notice: FDA seeks comments on a proposed information collection entitled “Study of Multiple Indications in Direct-to-Consumer Television Advertisements.” 09/15/2020

Survey on Physician Perceptions of Boxed Warnings
Federal Register notice: FDA sends to OMB a proposed information collection entitled “Healthcare Provider Perception of Boxed Warning Information Survey.” 09/15/2020

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