FDA Policy/General

Latest Federal Register Notices

Regulatory Review Period Set for Edwards’ Sapien Valve
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Edwards Lifesciences’ Sapien XT Transcatheter Heart Valve is 1,370 days. 02/02/2018

Workshop on Modeling/Simulation for Oncology Products
Federal Register notice: FDA announced a 2/1 public workshop entitled “Best Practices in Modeling and Simulation for Oncology Products.” 02/01/2018

Regulatory Review Period Determined for Corlanor
Federal Register notice: FDA determines that for patent extension purposes the regulatory review period for Les Laboratoires Servier’s Corlanor (ivabradine hydrochloride) was 293 days. 02/01/2018

Regulatory Review Period Determined for Merck’s Keytruda
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Merck’s Keytruda (pembrolizumab) to be 1,338 days. 01/31/2018

Meeting on Trial Inclusion/Exclusion Criteria
Federal Register notice: FDA plans a 4/16 public meeting on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” 01/31/2018

Draft Guide on Qualified Infectious Disease Designations
Federal Register notice: FDA makes available a draft guidance entitled “Qualified Infectious Disease Product Designation Questions and Answers.” 01/30/2018

Surgical Smoke Precipitator Put Into Class 2
Federal Register notice: FDA classifies the surgical smoke precipitator into Class 2 (special controls). 01/30/2018

Class 2 for Embolic Protection Temporary Catheter
Federal Register notice: FDA classifies the temporary catheter for embolic protection during transcatheter intracardiac procedures into Class 2 (special controls). 01/30/2018

Comments Sought on WHO Restrictions for Certain Narcotics
Federal Register notice: FDA provides interested parties with the opportunity to submit written comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on certain drug substances. 01/29/2018

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