FDA Policy/General

Latest Federal Register Notices

Comments Sought on CVM Dispute Resolution Info Collection
Federal Register notice: FDA seeks comments on an information collection extension about a guidance on dispute resolution procedures for CVM regulatory decisions. 10/27/2017

Draft Guide on Generic Drug User Fees
Federal Register notice: FDA releases a draft guidance on “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” 10/27/2017

FDA Draft Guide on Pediatric GERD Drug Development
Federal Register notice: FDA makes available a draft guidance entitled “Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.” 10/27/2017

Comments Sought on Dispute Resolution Guidance Extension
Federal Register: FDA seeks comments on an information collection extension related to a guidance on formal dispute resolution on drug GMP issues. 10/27/2017

Guide on 510(k)s for Device Changes
Federal Register notice: FDA makes available a guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” that clarifies when a change in a legally marketed medical device would require a 510(k) submission. 10/26/2017

Draft Guide on Breakthrough Device Program
Federal Register notice: FDA makes available a draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff” that describes policies the agency intends to use to implement the new Breakthrough Devices Program. 10/26/2017

2 Draft Guidances on Drug-Drug Interactions
Federal Register notice: FDA makes available two draft guidances entitled “In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies” and “Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications.” 10/25/2017

Ovrette Not Withdrawn Due to Safety/Effectiveness: FDA
Federal Register notice: FDA determines that HRA Pharma’s Ovrette (norgestrel) tablets, 0.075 mg, was not withdrawn from sale for reasons of safety or effectiveness. 10/25/2017

Class 2 for Zinc Transporter 8 Autoantibody Immunological Test
Federal Register notice: FDA classifies zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls).10/25/2017

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