Drugs

Latest Federal Register Notices

Adjunctive Cardiovascular Status Indicator Into Class 2
Federal Register notice: FDA classifies as Class 2 the adjunctive cardiovascular status indicator (special controls). 07/28/2017

List of Difficult Drugs for Compounding
Federal Register notice: FDA develops a list of drug products and categories of drug products that are difficult to compound. 07/28/2017

Device Software Precertification Pilot Program
Federal Register notice: CDRH announces a Software Precertification Pilot Program to evaluate a new approach for software products, including a precertification program for assessing companies that perform high-quality software design and testing. 07/28/2017

Class 2 Status for Balloon Aortic Valvuloplasty Catheter
Federal Register notice: FDA classifies the balloon aortic valvuloplasty catheter into Class 2 (special controls). 07/27/2017

IRB Waiver of Informed Consent Guidance Availability
Federal Register notice: FDA announces the availability of a guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” 07/26/2017

Technical Amendment to Civil Money Penalty Rule
Federal Register notice of technical amendment: FDA amends a final rule on “Civil Money Penalty Definitions.” 07/26/2017

ICH Revised Guide on CTD Efficacy
Federal Register notice: FDA announces the availability of a guidance on “M4E(R2): The CTD — Efficacy,” an International Council for Harmonization revised guidance that standardizes the presentation of benefit-risk information in regulatory submissions. 07/26/2017

FDA Workshop on Device Quality Pilot Program
Federal Register notice: FDA announces a 10/10 public workshop on “Voluntary Medical Device Manufacturing and Product Quality Program” to announce a proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality. 07/25/2017

FDA Re-org Moves Lab Science/Safety Under Commissioner’s Office
Federal Register notice: FDA announces a restructuring of its Office of the Commissioner, and Office of Operations. 07/25/2017

Guidance on Animal Drug User Fee Waivers
Federal Register notice: FDA announces the availability of a guidance for industry on “Animal Drug User Fees and Fee Waivers and Reductions.” 07/25/2017

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