FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Ross Lucien for five years from importing or offering for import any drug into the U.S. The action is related to Lucien’s recent conviction on one felony count of conspiracy to smuggle goods into the U.S. He previously
FDA Policy/General
Federal Register notice: FDA is issuing an order to permanently debar Kalpen D. Patel from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on his guilty plea for conspiracy to traffick in counterfeit drugs (cough syrup). To
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Use of Data Monitoring Committees in Clinical Trials.” The document is intended to assist trial sponsors in determining when a data monitoring committee would be useful for trial monitoring and what procedures and practices should be considered to guide
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service (PHS) Act. The rule codifies the agency’s existing practice that previously approved applications for certain biological products under the Federal Food,
FDA Policy/General
Federal Register notice: FDA is announcing a 5/20-21 public workshop entitled “FY 2024 Generic Drug Science and Research Initiatives Workshop.” The workshop is to provide an overview and status of science and research initiatives for generic drugs. It also provides an opportunity for public input on the initiatives.
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Brendon Gagne for five years from importing or offering for import any drug into the U.S. The order is based on Gagne’s felony conviction for conspiracy to smuggle a drug or controlled substance into the U.S. To view
FDA Policy/General
FDA commissioner Robert Califf says he wants the general public to feel despair about the growing problem of health misinformation and disinformation so they will “wake up and do something.” Speaking at a George Washington University School of Media and Public Affairs 2/6 presentation on “Responding to Mis- and
Drugs
Social and behavioral scientists working in the CDER Office of Communications are testing some Center drug-related messages and information to ensure they are clear and understandable to their target audiences. Alexandria Smith, a social scientist on the Research and Risk Communications staff, says in an online post that the
FDA Policy/General
Federal Register notice: FDA is seeking comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received will be considered in preparing the U.S. position on these proposals for a meeting of the United
FDA Policy/General
Federal Register notice: FDA announces a 3/5 meeting of the Vaccines and Related Biological Products Advisory Committee. Panel members are scheduled to discuss and make recommendations on selecting strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is publishing a list of six information collections that have been approved by OMB. They are: * Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies * Orphan Drugs * Medical Devices; Device Tracking * Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have
FDA Policy/General
Writing 2/3 in the New England Journal of Medicine, FDA commissioner Robert Califf, chief medical officer Hilary Marston, and senior advisor for chronic diseases Haider Warraich discuss how FDA uses its role as a regulatory, scientific, and public health agency to “support the development of effective and accessible interventions
FDA Policy/General
Three SheppardMullin attorneys say a recent CDER Office of Prescription Drug Promotion (OPDP) untitled letter to Novartis alleging that a direct-to-consumer (DTC) TV ad for its breast cancer drug Kisqali (ribociclib) made false or misleading efficacy representations is a good reminder that those working on such ads should
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act.” The document addresses the process that should be used by registrants of drug establishments to submit reports on
FDA Policy/General
Federal Register notice: FDA is announcing a 3/21 meeting of the Medical Devices Advisory Committee’s Ophthalmic Devices Panel. Committee members are scheduled to discuss a de novo marketing request by Balance Ophthalmics for its FSYX Ocular Pressure Adjusting Pump System, indicated as adjunctive therapy for reducing intraocular pressure
FDA Policy/General
Federal Register notice: FDA is revoking the Emergency Use Authorizations (EUAs) issued to Southern California Permanente Medical Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, and Drexel University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. The revocations were requested by the
FDA Policy/General
Federal Register notice: FDA is announcing a 3/15 Oncologic Drugs Advisory Committee meeting. Panel members in the morning are scheduled to discuss a Janssen Biotech supplemental BLA for Carvykti (ciltacabtagene autoleucel) and its use in treating adult patients with relapsed or refractory multiple myeloma and who have received at
FDA Policy/General
FDA Commissioner Robert Califf says artificial intelligence (AI) embedded in clinical decision support or the integration of AI into clinical practice is at a really interesting phase, and it is going to “grow like wildfire,” requiring the agency to hire “three or four times as many people to take on
FDA Policy/General
The Center for Veterinary Medicine has published two data element guidances. The first guidance, Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine, is to help applicants and non-applicants to complete form FDA-1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize the regulation with international consensus standards. The rule is effective 2/2/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting a 12/21/2023 notice announcing the availability of a final guidance entitled “Development of Monoclonal Antibody Products Targeting SARS–CoV–2 for Emergency Use Authorization.” The notice was published with an incorrect docket number, which has now been corrected to read “Docket No.
FDA Policy/General
Federal Register notice: FDA is announcing a 3/14 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Geron NDA for imetelstat for injection, indicated for treating transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or