FDA Policy/General

Latest Federal Register Notices

Hep D Virus Drug Development Guide
Federal Register notice: FDA makes available a draft guidance entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.” 11/01/2019

Draft Guide on Generic Drug User Fees
Federal Register notice: FDA makes available a draft guidance entitled “Assessing User Fees under the Generic Drug User Fee Amendments of 2017.” 11/01/2019

Panel to Review Correvio Atrial Fibrillation Drug
Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Correvio International NDA for its atrial fibrillation drug. 11/01/2019

Mexitil Not Withdrawn Over Safety/Efficacy: FDA
Federal Register notice: FDA determines that Boehringer Ingelheim’s Mexitil (mexiletine hydrochloride) was not withdrawn from sale for safety or effectiveness reasons. 10/31/2019

Meeting on Health Equity Related to Opioid Crisis
Federal Register notice: FDA announces an 11/21 public meeting entitled “Office of Minority Health and Health Equity Public Meeting on Strategies to Improve Health Equity Amidst the Opioid Crisis.” 10/31/2019

Draft Guide on IND Safety Report eSubmissions
Federal Register notice: FDA makes available a draft guidance on “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” 10/30/2019

FDA Withdrawing Watson Labs Oxycodone Hydrochloride
Federal Register notice: FDA proposes to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this action. 10/29/2019

FDA Withdrawing InvaGen Trandolapril ANDA
Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets. 10/29/2019

National Center for Toxicological Research Panel Meeting 12/3-4
Federal Register notice: FDA announces a 12/3-4 Science Advisory Board to the National Center for Toxicological Research advisory committee meeting. 10/29/2019

Class 1 for Continuous Glucose Monitor Data Systems
Federal Register notice: FDA classifies continuous glucose monitor data management systems into Class 1 (general controls). 10/29/2019

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