FDA Policy/General

Latest Federal Register Notices

Final Guide on REMS Factors
Federal Register notice: FDA makes available a final guidance entitled “Risk Evaluation and Mitigation Strategy: FDA’s Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.” 04/05/2019

Cortisporin Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Monarch Pharmaceuticals’ Cortisporin (hydrocortisone/neomycin sulfate/polymyxin B sulfate) was not withdrawn from sale for reasons of safety or effectiveness. 04/05/2019

Qvar Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Teva’s Qvar 40 and Qvar 80 (beclomethasone dipropionate HFA) inhalation aerosol products were not withdrawn from sale for reasons of safety or effectiveness. 04/05/2019

Info Collection on Prom Material eSubmissions
Federal Register notice: FDA proposes a new information collection on “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.”04/04/2019

Hearing on Cannabis Products
Federal Register notice: FDA announces a 5/31 public hearing to obtain scientific data and information about products containing cannabis or cannabis-derived compounds. 04/04/2019

Info Collection on Emergency Use Authorizations
Federal Register notice: FDA seeks comments on an information collection extension related to its “Guidance: Emergency Use Authorization of Medical Products and Related Authorities.” 04/04/2019

Info Collection on Medical Device Accessories
Federal Register notice: FDA seeks comments on an information collection extension related to a guidance entitled “Medical Device Accessories.” 04/04/2019

Hearing on Developing Affordable Insulin Products
Federal Register notice: FDA announces a 5/13 public hearing to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products. 04/03/2019

Chlor–Trimeton Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that Bayer’s Chlor–Trimeton Allergy 12 Hour (chlorpheniramine maleate) extended release tablets 8mg and 12mg were not withdrawn from sale for reasons of safety or effectiveness. 04/03/2019

Onfi Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Lundbeck Pharmaceuticals’ Onfi (clobazam) tablets 5mg were not withdrawn from sale for reasons of safety or effectiveness. 04/03/2019

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

Read more

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