FDA Policy/General

Latest Federal Register Notices

Priority Review Voucher Awarded to AveXis
Federal Register notice: FDA announces that it issued a priority review voucher to AveXis for gaining approval for its rare pediatric disease product Zolgensma (onasemnogene abeparvovec-xioi). 06/21/2019

Panel to Review Gilead sNDA for Descovy
Federal Register notice: FDA announces an 8/7 Antimicrobial Drugs Advisory Committee meeting to discuss a Gilead Sciences supplemental NDA for Descovy. 06/21/2019

Draft Guide on Opioid Benefit-Risk Assessments
Federal Register notice: FDA makes available a draft guidance entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.” 06/21/2019

Hearing on Standards for Future Opioid Analgesic Approvals
Federal Register notice: FDA announces a 9/17 public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” 06/20/2019

Info Collection for GRAS Substance Notifications
Federal Register notice: FDA submits to OMB an information collection extension for “Substances Generally Recognized as Safe (GRAS): Notification Procedure.” 06/20/2019

Pediatric Oncology Subcommittee Meeting Amended
Federal Register notice: FDA amends a 5/6 Federal Register notice about a 6/20 meeting of the Oncologic Drugs Advisory Committee’s Pediatric Oncology Subcommittee. 06/20/2019

Comments Extended for Cannabis Product Info
Federal Register notice: FDA extends the comment period until 7/16 that seeks input and scientific data about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis. 06/19/2019

Info Collection on OTC Drug Labeling Format
Federal Register notice: FDA seeks comments on an information collection extension entitled “Format and Content Requirements for Over-the-Counter Drug Product Labeling — 21 CFR Part 201.” 06/19/2019

Info Collection Extension for Social/Behavioral Research
Federal Register notice: FDA seeks comments on an information collection extension for “Data to Support Social and Behavioral Research as Used by the Food and Drug Administration.” 06/18/2019

Info Collection Extension on Device Postmarket Surveillance
Federal Register notice: FDA seeks comments on an information collection extension entitled “FDA Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). 06/18/2019

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