FDA Policy/General

Latest Federal Register Notices

Priority Voucher Redeemed for Alexion’s Ultomiris
Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher — Alexion Pharmaceuticals’ Ultomiris (ravulizumab-cwvz). 05/03/2019

Update to Susceptibility Test Interpretive Criteria Page
Federal Register notice: FDA has made available its annual compilation of updates to the Susceptibility Test Interpretive Criteria Web page. 05/03/2019

Patient Preference-Sensitive Priorities
Federal Register notice: FDA makes available a list of patient preference-sensitive priorities on FDA’s Web site entitled “Patient Preference-Sensitive Areas: Using Patient Preference Information in Medical Device Evaluation.” 05/03/2019

International Cosmetics Regulation Meeting
Federal Register notice: FDA announces a 6/5 public meeting entitled “International Cooperation on Cosmetics Regulation (ICCR) — Preparation for ICCR-13 Meeting.” 05/02/2019

Info Collection Extension for Mammography Requirements
Federal Register notice: FDA seeks comments on an information collection extension for “Mammography Quality Standards Act Requirements — 21 CFR Part 900.” 05/01/2019

Workshop on Adenoviral Infection Drug Development
Federal Register notice: FDA announces an 8/8 public workshop entitled “Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients.” 05/01/2019

Info Collection on Xenotransplant Infectious Disease Guide
Federal Register notice: FDA submits to OMB an information collection extension for “Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation.” 04/30/2019

Info Collection on Device Detention
Federal Register notice: FDA sends to OMB an information collection extension for “Administrative Detention and Banned Medical Devices — 21 CFR 800.55(g)(1), (g)(2), and (k), 895.21(d), and 895.229(a).” 04/29/2019

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