FDA Policy/General

Latest Federal Register Notices

Public Meeting on Pediatric Device Development
Federal Register notice: FDA announces an 8/13-14 public meeting entitled “Pediatric Medical Device Development.” 02/16/2018

Guide on How to Prepare Combination Product Designation Request
Federal Register notice: FDA makes available a guidance entitled “How to Prepare a Pre-Request for Designation (Pre-RFD).” 02/16/2018

Lotensin HCT Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that U.S. Pharmaceutical Holdings’ Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. 02/16/2018

Draft Guide on eSubmission Data for BIMO Inspection Prep
Federal Register notice: FDA makes available a draft guidance entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections for CDER Submissions.’’ 02/16/2018

Panel to Review Akcea Therapeutics NDA in May
Federal Register notice: FDA announces a 5/10 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review Akcea Therapeutics NDA. 02/16/2018

Oncologic Drugs Panel Meeting to Review Amgen sBLA
Federal Register notice: FDA announces a 3/7 Oncologic Drugs Advisory Committee meeting to review Amgen supplemental BLA for Blincyto. 02/15/2018

Guide on Pharmaceutical Co-Crystals
Federal Register notice: FDA makes available a guidance entitled “Regulatory Classification of Pharmaceutical Co-Crystals.” 02/15/2018

Hemostatic Gauze Placed in Class 2
Federal Register notice: FDA classifies the non-absorbable, hemostatic gauze for temporary internal use into Class 2 (special controls). 02/15/2018

Proposed Rule on Animal Drug ADR eSubmissions
Federal Register proposed rule: FDA proposes to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted in an electronic format. 02/14/2018

Workshop on Rare Disease Statistical Methods/Trial Designs
Federal Register notice: FDA announces a 3/19 workshop on “Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings.” 02/14/2018

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