FDA Policy/General
Knowledge Ecology International (KEI), which petitioned FDA in 2020 asking it to ban the use of background music during the presentation of risks in direct-to-consumer (DTC) drug ads, says three groups and seven individuals submitted 5/10 comments to the agency supporting the petition. The petition had already
FDA Policy/General
FDA commissioner Robert Califf and chief medical officer Hilary Marston say the agency is learning from experiences during the Covid-19 public health emergency to better prepare for future public health emergencies, supply chain disruptions, geopolitical changes, and natural disasters. Writing in an FDA Voices online post, Califf and Marston
FDA Policy/General
Federal Register notice: FDA is announcing the publication of a discussion paper entitled “Using Artificial Intelligence (AI) and Machine Learning (ML) in the Development of Drug and Biological Products.” The agency is soliciting feedback on the opportunities and challenges with using AI/ML in drug development, as well as medical
FDA Policy/General
Federal Register notice: FDA has determined that Roxane Laboratories’ hydrochlorothiazide oral solution, 50 mg/5 mL was not withdrawn from sale due to safety or effectiveness concerns. The determination allows the agency to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory
FDA Policy/General
FDA has issued ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease. The letter cites deficiencies related to
FDA Policy/General
Federal Register notice: FDA has announced a 6/16 Oncologic Drugs Advisory Committee meeting of its Pediatric Oncology Subcommittee that will discuss dosage optimization in children with cancer. Discussion topics include variability in pharmacokinetic and pharmacodynamic parameters by age and size, the need for age-appropriate formulations, potential for toxicities
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.” The document provides updated recommendations on testing to help pharmaceutical manufacturers, repackers, other suppliers, and
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of three emergency use authorizations (EUAs) for Covid-19 tests because they are no longer being manufactured or distributed in the U.S. The affected tests are: * Thermo Fisher Scientific’s OmniPATH Covid–19 Total Antibody ELISA Test * Detect’s Covid–19
FDA Policy/General
FDA says it is working with the National Institute of Standards and Technology on a project to generate needed resources for researchers and companies creating innovative animal biotechnology products by using genome editing to alter the genome of animals. An agency announcement says genome editing technology has “revolutionized the ability
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Somscan’s Detectnet (copper Cu-64 dotatate), a radioactive diagnostic agent indicated for use with positron emission tomography for localization of somatostatin receptor positive neuroendocrine tumors in adult patients. The regulatory review period is
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use.” The collection supports electronic Form FDA 3926 “Individual Patient Expanded Access Investigational New Drug Application (IND).” The form requires the completion of data fields that enable the agency to
FDA Policy/General
FDA commissioner Robert Califf is warning that large language models (LLMs) and their use by industry will require regulation because the agency runs the risk of being “swept up quickly by something that we hardly understand.” ChatGPT and other models are becoming more accessible to the public and their use
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Q9(R1) Quality Risk Management.” The International Council for Harmonization document addresses product availability risks due to manufacturing quality issues, lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work, lack of clarity on risk-
FDA Policy/General
Federal Register notice: FDA has released a list of 15 information collections that have been recently approved by OMB. They are: * Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation B12 Pediatric Device Survey * Electronic Products Requirements * Investigational Device Exemptions * General Drug Labeling Provisions and OTC Monograph Drug
FDA Policy/General
Federal Register notice: FDA has determined that Bayer’s Levitra (vardenafil HCl) oral tablets (5mg, 10mg and 20mg) were not withdrawn from sale due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the products as long as they meet relevant legal and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Decentralized Clinical Trials (DCT) for Drugs, Biological Products, and Devices.” The document describes a DCT as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. To view
FDA Policy/General
FDA commissioner Robert Califf says FDA needs improved operational readiness with its inspection oversight to be prepared for the next pandemic. Testifying 5/4 at a Senate hearing on reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), Califf shared agency lessons learned during Covid-19 and outlined critical authorities
FDA Policy/General
Federal Register notice: FDA has announced a 6/15 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the selection of strain(s) to be included in the Covid–19 vaccines for the 2023–2024 vaccination campaign (fall to winter). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has created a docket to receive public comments on the identification, assessment, and control of N-nitrosamine (nitrosamine) drug substance-related impurities (NDSRIs). The agency has identified scientific and regulatory considerations regarding NDSRIs, including areas that may benefit from collaborative efforts, and requests comments on the
FDA Policy/General
Federal Register notice: FDA is correcting a 4/24 notice entitled “Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches” because it contained an incorrect topic for discussion. The corrected topic now reads: “Science- and risk-based approaches for developing and assessing innovative technologies across platform products and
FDA Policy/General
Federal Register notice: FDA has announced a 6/8 Antimicrobial Drugs Advisory Committee meeting to discuss an AstraZeneca BLA for nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use. The proposed indication is preventing RSV lower respiratory tract disease in neonates, infants and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” The collection supports FDA regulations that establish minimum GMP requirements for supplements to ensure their quality, such as recordkeeping,