FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Human Gene Therapy Products Incorporating Human Genome Editing.” The document provides recommendations to sponsors developing human gene therapy products incorporating genome editing of human somatic cells. It also discusses the information that should be provided in an IND application
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The document provides CAR T cell-specific recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and design of clinical studies for oncology indications (including hematologic malignancies
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” The document provides recommendations on the use of a standardized approach for collecting and reporting race and ethnicity data in submissions including
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled “Conducting Remote Regulatory Assessments — Question and Answers.” The document was revised in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act. It describes the agency’s current thinking regarding its use of
FDA Policy/General
Federal Register notice: FDA is making available a final document entitled “Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products.” The document was mandated under the 21st Century Cures Act, which requires the agency to make publicly available the best practices for certain
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Vaccines and Related Biological Products Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/31/2025. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Revising ANDA Labeling Following Revision of the RLD Labeling.” The document provides recommendations for updating ANDA labeling following revisions to the labeling of a reference-listed drug (RLD), including information on how to identify RLD labeling updates and how
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices authorized in 2023. The authorizations contain, among other things, conditions on the emergency use of the authorized products, and they include an explanation of the reasons for issuance. To view the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Good Manufacturing Practice for Active Pharmaceutical Ingredients (APIs) Used in Veterinary Medicinal Products.” The document provides recommendations on GMPs associated with manufacturing APIs under an appropriate system for managing quality. It is also intended to help ensure that APIs
FDA Policy/General
FDA has published a Veterinary International Conference on Harmonization guidance, Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products, to give guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. The document says it also is
FDA Policy/General
Twenty-eight non-profit groups representing the CBD (cannabidiol) and hemp industries are calling on Congress to hold a hearing soon on FDA’s regulation, or lack thereof, of the growing market. In a 1/24 letter to the House Energy and Commerce Committee, the groups urge a hearing to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring — 21 CFR Part 315.” The collection supports agency regulations that require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new
FDA Policy/General
Federal Register notices: FDA announces that a priority review voucher was redeemed in the approval of the following products: * Astellas Pharma’s Veozah (fezolinetant), indicated for treating moderate to severe vasomotor symptoms, or hot flashes, caused by menopause (see notice here.) * Novartis’ Cosentyx (secukinumab) for treating active non-radiographic axial
Drugs
Two Generation Patient executives and a Dartmouth Institute for Health Policy and Clinical Practice professor say FDA and the Federal Trade Commission (FTC) need to develop and clarify regulations to protect patients from potential harm and misleading information on social media platforms, particularly from influencers. Writing in a StatNews post,
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has faulted a Novartis direct-to-consumer TV ad promoting it breast cancer therapy Kisqali (ribociclib) for false or misleading efficacy representations. “This violation is particularly concerning because the overstated representations about Kisqali’s efficacy could lead patients with advanced or metastatic
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements — 21 CFR Part 203.” The collection supports agency regulations that set requirements for the: (1) reimportation and wholesale distribution of prescription drugs; (2) sale, purchase, or trade of, or
FDA Policy/General
Federal Register notice: FDA is announcing that a product was approved that redeemed a material threat medical countermeasure priority review voucher — Abbvie’s Qulipta (atogepant) tablets, indicated for preventing migraines in adults. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing a 3/5 Medical Imaging Drugs Advisory Committee meeting to review a Lumicell NDA for pegulicianine for injection. The optical imaging drug constituent of the company’s drug/device combination product has a proposed indication for use in patients with breast cancer to assist
FDA Policy/General
Federal Register notice: FDA has announced that an information collection entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” has been approved by OMB. The approval expires on 12/31/2026. To view the notice, click here.Federal Register notice: FDA has announced that
FDA Policy/General
Speaking at the Consumer Technology Association’s “Ask A Commissioner” program at last week’s Consumer Electronics Show in Las Vegas, FDA commissioner Robert Califf said the agency can’t be solely responsible for effectively regulating products with adaptive algorithms that can learn and change. “If you have an algorithm
FDA Policy/General
Federal Register notice: FDA has revised an information collection entitled “Premarket Notification for a New Dietary Ingredient (NDI) — 21 CFR 190.6.” Its collection is revised based on recommendations in a 2016 guidance entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the approval of a product that redeemed a material threat medical countermeasure priority review voucher — Novartis’ Fabhalta (iptacopan), indicated as monotherapy for treating adults with paroxysmal nocturnal hemoglobinuria. The agency determined that the drug application, which was approved 12/5/2023, met the voucher