FDA Policy/General

Latest Federal Register Notices

Comments Sought on Cannabis Scheduling Recommendations
Federal Register notice: FDA seeks comments on World Health Organization recommendations to impose international manufacturing and distributing restrictions on certain cannabis drug substances. 03/01/2019

Comments Sought on Fentanyl Scheduling Recommendations
Federal Register notice: FDA is seeking comments on World Health Organization drug scheduling recommendations on fentanyl-related narcotic drugs. 03/01/2019

Meeting on Rare Disease Patient Perspectives
Federal Register notice: FDA announces a public meeting and an opportunity for public comment on “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.” 02/28/2019

New Address for Generic Drugs Document Room
Federal Register notice: FDA amends its regulations to reflect a change of address for CDER’s Office of Generic Drugs Document Room from Rockville, MD, to Beltsville, MD. 02/28/2019

Info Collection Extension for Formal Dispute Resolution
Federal Register notice: FDA submits to OMB an information collection extension entitled “Formal Dispute Resolution; Appeals Above the Division Level.” 02/27/2019

Draft Guide on Drug Continuous Manufacturing
Federal Register notice: FDA makes available a draft guidance entitled “Quality Considerations for Continuous Manufacturing.” 02/27/2019

National Center for Toxicological Research Advisory Committee
Federal Register notice: FDA announces a 3/19-20 meeting of the National Center for Toxicological Research’s Science Advisory Board. 02/27/2019

Proposed Rule on OTC Sunscreen Monograph
Federal Register notice: FDA issues a proposed rule to put into effect a final monograph for nonprescription, over-the-counter sunscreen drug products. 02/26/2019

Draft Guide on Drug Food-effect Studies
Federal Register notice: FDA makes available a draft guidance entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” 02/26/2019

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