FDA Policy/General

Latest Federal Register Notices

Comments Reopened on Real World Evidence Program
Federal Register notice: FDA reopens the comment period on a 12/7/2018 notice entitled “Framework for a Real-World Evidence Program; Availability.” 02/15/2019

Panel to Discuss Breast Implant Benefit/Risk
Federal Register notice: FDA announces a 3/25-26 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting that will discuss benefits and risks of breast implants indicated for breast augmentation and reconstruction. 02/15/2019

Established Conditions Pilot Program for Drugs
Federal Register notice: CDER provides an opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program. 02/15/2019

Info Collection Extension on Export Notifications/Recordkeeping
Federal Register notice: FDA seeks comments on an information collection extension for “Exports: Notification and Recordkeeping Requirements — 21 CFR 1.101.” 02/15/2019

Lotrimin Not Withdrawn Over Safety/Efficacy: FDA
Federal Register notice: FDA determines that Schering-Plough Healthcare Products’ Lotrimin (clotrimazole) topical solution, 1%, was not withdrawn from sale for safety or effectiveness reasons. 02/14/2019

Guide on CDER Quality Consensus Standards Program
Federal Register notice: FDA makes available a draft guidance entitled “CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.” 02/14/2019

Takeda’s Omontys Withdrawm Due to Adverse Events
Federal Register notice: FDA announces the withdrawal of a Takeda Pharmaceuticals NDA for Omontys (peginesatide) injection, indicated for treating anemia due to chronic kidney disease in adult patients on dialysis. 02/14/2019

Regulatory Review Determined for Anacor Pharma’s Eucrisa
Federal Register notice: FDA determines the regulatory review period for Anacor Pharmaceuticals’ Eucrisa (crisaborole), indicated for topical treatment of mild to moderate atopic dermatitis. 02/13/2019

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