FDA Policy/General

Latest Federal Register Notices

Panel to Discuss Chikungunya Vaccine Development
Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chikungunya vaccine development. 08/23/2019

Correction on Opioids Hearing
Federal Register notice correction: FDA corrects a 6/21 notice entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing.” 08/22/2019

Zonegran Not Withdrawn Due to Safety/Efficacy: FDA
Federal Register notice: FDA determines that Sunovion Pharmaceuticals’ Zonegran (zonisamide) was not withdrawn for safety or effectiveness reasons. 08/22/2019

Joint Panel to Review Pediatric-use Opioids
Federal Register notice: FDA announces a 9/26 joint advisory committee meeting to discuss the pediatric-focused safety review for oxycodone hydrochloride extended-release tablets. 08/21/2019

Info Collection Extension for Med Guides
Federal Register notice: FDA sends to OMB an information collection extension for drug Medication Guide Requirements. 08/21/2019

Info Collection on Patent Term Restoration Petitions
Federal Register notice: FDA seeks comments on an information collection extension for “Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions 21 CFR part 60.” 08/21/2019

Antimicrobial Drugs Panel to Review Antibiotic
Federal Register notice: FDA announces a 10/16 Advisory Committee meeting to review a Shionogi NDA for antibiotic for urinary tract infections. 08/20/2019

Panel to Review Agile Transdermal Contraceptive
Federal Register notice: FDA sets a 10/30 advisory committee meeting to review an Agile Therapeutics transdermal contraceptive. 08/20/2019

Pilot on CDISC Non-Clinical Study Data eSubmission
Federal Register notice: FDA announces a pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium. 08/20/2019

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