FDA Policy/General
Life expectancy in the U.S. is three to five years lower than the average in other high-income countries and one reason is the extent of health misinformation. That’s the view of FDA commissioner Robert Califf, presented in a wide-ranging interview with CNBC. “It’s looking worse,
FDA Policy/General
Federal Register notice: FDA has announced a 5/18 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfizer BLA for Abrysvo (respiratory syncytial virus vaccine). The submission is seeking an indication for preventing lower respiratory tract disease and severe lower respiratory tract disease caused by respiratory syncytial
FDA Policy/General
Federal Register notice: FDA has announced a 6/9 Peripheral and Central Nervous System Drugs Advisory Committee to review an Eisai supplemental BLA for Alzheimer’s drug Leqembi (lecanemab) solution for intravenous infusion. The submission includes a confirmatory study that seeks to convert the drug’s current accelerated approval to
FDA Policy/General
Federal Register notice: FDA is announcing a 5/12 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Sarepta Therapeutics BLA for delandistrogene moxeparvovec. The submission is seeking an indication for treating ambulatory patients with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. To
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Imports and Electronic Import Entries” (OMB Control Number 0910-0046). The collection supports agency regulations governing import activities and related agency guidance. The regulations prescribe required data elements that respondents must submit when importing, or offering for
FDA Policy/General
Federal Register notice: FDA is adding quinacrine hydrochloride to its list of bulk drug substances (active pharmaceutical ingredients for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for exemptions from the
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a draft guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.” Comments now can be submitted until 5/15. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.” The document is the last of four in a series of methodological patient-focused guidances that describe how stakeholders (patients, researchers, medical product developers, and
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The document provides recommendations to manufacturers about providing FDA timely, informative notifications about changes in the production of certain finished drugs
FDA Policy/General
FDA has accepted for review an Accord BioPharma BLA for HLX02, a proposed trastuzumab (Roche’s Herceptin) biosimilar for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The submission, according to
FDA Policy/General
CDER director Patrizia Cavazzoni says the Center is in “growth mode” after the user fee reauthorization on 9/30/2022, and focused on hiring and staff retention. Speaking at an online Alliance for a Stronger FDA 4/5 update, Cavazzoni said CDER’s staff is over the 5,600 level
FDA Policy/General
Federal Register notice: FDA announces the availability of a draft guidance entitled “Human User Safety (HUS) in New and Abbreviated New Animal Drug Applications.” The document is intended to clarify the current approaches and CVM’s recommendations) for HUS assessments and information submissions to support the overall safety of proposed
FDA Policy/General
FDA has released a draft guidance entitled “Human User Safety in New and Abbreviated New Animal Drug Applications.” The agency says that the FD&C Act does not provide specific guidance on data requirements or assessment methods to identify the risks or risk mitigation measures for human users of
FDA Policy/General
Federal Register notice: FDA has established a docket to obtain information and comments to help assess whether in-home disposal products can be expected to meet the public health goal of mitigating the risk of nonmedical use or overdose if the agency were to require drug manufacturers to make in-
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Infectious Otitis Externa Drugs for Topical Use in Dogs.” The document provides recommendations to help sponsors complete the effectiveness, target animal safety, and labeling technical sections of a new animal drug application for such products. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” The document describes a least burdensome approach that would support iterative improvement through modifications to machine learning-enabled device
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP.” The document is intended to assist IRBs, sponsors, and investigators in understanding the processes used for reviewing research involving children
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Prescription Drug Advertising” (OMB Control Number 0910-0686). The collection supports agency regulations that require manufacturers who advertise prescription drugs/biologics to disclose in their ads certain information about the product’s uses and risks. It is
FDA Policy/General
Federal Register notice: FDA has announced a 4/14 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee. Panel members are scheduled to discuss an Otsuka Pharmaceutical and Lundbeck supplemental NDA for Rexulti (brexpiprazole) tablets for treating agitation associated with Alzheimer’
FDA Policy/General
Midwest Veterinary Supply, based in Minnesota, has pleaded guilty to introducing misbranded veterinary drugs into interstate commerce and will pay more than $10 million in criminal fines and forfeiture. A Department of Justice news release says the company supplies prescription drugs for animals to veterinarians, farms, feedlots, and other businesses.
FDA Policy/General
FDA commissioner Robert Califf says that proposed budget cuts of up to 22% being floated by Republican lawmakers would have a devasting effect on the agency and the industries it serves. Testifying at a 3/29 House Appropriations Subcommittee hearing, Califf was asked by ranking member Sanford Bishop (D-GA)
FDA Policy/General
Federal Register notice: FDA has announced a 5/9 joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee. Panel members are scheduled to discuss a Laboratoire HRA Pharma supplemental NDA for Opill (norgestrel), indicated for nonprescription use as a once-daily oral