FDA Policy/General

Latest Federal Register Notices

FDA Seeks Nominations for Radiation Standards Panel
Federal Register notice: FDA requests nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee.
06/16/2017

FDA Seeks Consumer Reps for Advisory Panels
Federal Register notice: FDA requests nominations for voting and nonvoting consumer representatives to serve on advisory committees and panels.
06/16/2017

Comments Sought on Drug Compounding Facility Fees
Federal Register notice: FDA seeks comments on an information collection extension for “Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.”
06/15/2017

Comments Sought on Animal Drug User Fee Cover Sheet
Federal Register notice: FDA seeks comments on an information collection extension for “Form FDA 3728, Animal Generic User Fee Act Cover Sheet.”
06/15/2017

Comments Sought in Social/Behavioral Research Data
Federal Register notice: FDA seeks comments on a new information collection on “Data To Support Social and Behavioral Research as Used by the Food and Drug Administration — OMB Control Number 0910.”
06/15/2017

Nominations Sought for Industry Rep on Device GMP Panel
Federal Register notice: FDA seeks notice from industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee.
06/14/2017

Comments Sought on New Drug Promotion Research on Disclosures
Federal Register notice: FDA seeks comments on proposed research entitled “Disclosures in Professional and Consumer Prescription Drug Promotion.”
06/14/2017

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