FDA Policy/General

Latest Federal Register Notices

Quality Metrics Proposal Period Extended
Federal Register notice: FDA extends the proposal period for its “Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff” to allow interested persons additional time to submit a proposal. 08/17/2018

Info Collection Extension for Generic Development Guide
Federal Register notice: FDA submits to OMB an information collection extension entitled “Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.” 08/17/2018

Device Alternative Malfunction Reporting
Federal Register notice: FDA grants an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. 08/17/2018

Proposal to Classify Device Accessories into Class 1
Federal Register notice: FDA identifies a list of device accessories for which it believes general controls are sufficient to provide reasonable assurance of safety and effectiveness. 08/17/2018

Workshop on Microbiome-Based Products
Federal Register notice: FDA announces a 9/17 workshop entitled “Science and Regulation of Live Microbiome-Based Products Used To Prevent, Treat, or Cure Diseases in Humans.” 08/17/2018

Comments Sought on IND Surveys Under User Fee Program
Federal Register notice: FDA seeks comments on a new information collection entitled “Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI).” 08/16/2018

Priority Preview Voucher Granted to Ultragenyx
Federal Register notice: FDA issued a priority review voucher to Ultragenyx Pharmaceutical for its approved rare pediatric disease product application. 08/15/2018

Joint Advisory Panel to Discuss Modernizing Drug Assessments
Federal Register notice: FDA announces a 9/20 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting that will discuss modernizing drug application assessments. 08/15/2018

FDA Withdraws 20 Unmarketed ANDAs
Federal Register notice: FDA withdraws the approval of 20 ANDAs from multiple applicants. 08/14/2018

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