FDA Policy/General

Latest Federal Register Notices

Arthritis Drugs Panel to Review Eli Lilly NDA
Federal Register notice: FDA announces a 4/23 Arthritis Advisory Committee meeting that will review an Eli Lilly NDA for baricitinib tablets. 03/16/2018

Comments Sought on MedWatch Info Collection
Federal Register notice: FDA seeks comments on an information collection extension for “MedWatch: The FDA Medical Products Reporting Program” (OMB Control Number 0910-0291). 03/16/2018

Joint Advisory Panel Discussing Achondroplasia Amended
Federal Register notice: FDA amends a 1/23 notice about a 3/22 Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting to reflect a change in the agenda. 03/16/2018

Comments Sought on Professional Rx Promotion
Federal Register notice: FDA seeks comments on a proposed collection of information — “Health Care Professional Survey of Professional Prescription Drug Promotion.” 03/15/2018

FDA Exempts OTC Denture Repair Kits
Federal Register notice: FDA issues an order exempting from premarket notification (510(k) requirements over-the-counter denture repair kits. 03/15/2018

Lynch Syndrome Test Classification Notice Corrected
Federal Register correction notice: FDA corrects a final order entitled “Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems. 3/14/2018

4 Sun Pharma ANDA Approvals Withdrawn
Federal Register notice: FDA withdraws approval of four Sun Pharmaceutical ANDAs because the drug products are no longer marketed. 03/14/2018

Meeting on Opioid Use Disorder Drugs
Federal Register notice: FDA announces a 4/17 public meeting entitled “Patient-Focused Drug Development on Opioid Use Disorder.” 03/14/2018

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