Drugs
FDA has lifted a clinical hold against Astellas Pharma and its FORTIS Ph1/2 clinical trial evaluating AT845, an adeno-associated virus gene replacement therapy in adults with late-onset Pompe disease. The hold was placed 6/27/2022 following a report of peripheral sensory neuropathy in one of the
Drugs
The International Conference on Harmonization (ICH) has released a final guide entitled Quality Risk Management Q9 (R1), which has been adopted by FDA for implementation. The document is intended to offer a systematic approach to quality risk management that leads to better informed decisions. “It serves as a foundation or
Devices
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)).” Agency regulations authorize FDA to require: (1) manufacturers to report medical device-related deaths, serious injuries, and malfunctions and (2) user facilities to report device-related
Drugs
House Energy and Commerce Committee ranking member Frank Pallone (D-NJ) has written to FDA and the National Institutes of Health (NIH) with a concern about the “lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the ClinicalTrials.gov database.” His 1/
Drugs
FDA has denied a 7/22/22 Fresenius Kabi petition asking the agency to designate the company’s glycopyrrolate intramuscular, intravenous solution 0.6 mg/3 mL as therapeutically equivalent (TE) with an AP rating to Hikma Pharmaceutical’s Robinul (glycopyrrolate injection 0.2 mg/mL). The agency’s 1/
Drugs
Attorneys James Bolani and Bonnie Odom (Epstein Becker Green) say a small section buried in the Consolidated Appropriations Act of 2023 clarified the regulatory status of contrast agents, radioactive drugs, and over-the-counter monograph drugs. “The new law brings to an end the uncertainty regarding the regulatory status of
FDA Policy/General
FDA has issued a draft guidance #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The document is intended for sponsors interested in pursuing approval of new heartworm prevention products for dogs. The guidance says that the recommended approach to demonstrate
Devices
FDA says a Surmodics PMA application for its SurVeil drug-coated balloon is currently not approvable. A company statement says the agency provided guidance for a path forward, indicating that certain biocompatibility and labeling information should be added to the PMA through an amendment to place it in an approvable
Devices
FDA says it is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The final rule says
Biologics
FDA has released a draft guidance entitled “Mpox: Development of Drugs and Biological Products.” The document provides nonclinical, virology, and clinical considerations for mpox drug development programs, and it includes recommendations to support initiation of clinical trials. The guidance notes that preventive vaccines are not addressed in the document because
Drugs
FDA has asked a Florida federal court to issue a permanent injunction against LGM Pharma, headquartered in Boca Raton, FL, and two of its executives. The agency’s 1/11 complaint says LGM imports and distributes drugs, including active pharmaceutical ingredients, from a facility in Erlanger, KY. FDA inspected the
Drugs
FDA has released the form FDA-483 issued following an 11/22-12/2/22 inspection at Intas Pharmaceuticals in Ahmedabad, Gujarat, India. The 11 inspection observations were: * laboratory records do not include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and
Devices
FDA has cleared a Realize Medical 510(k) for its Elucis virtual reality software for surgical planning. The device is intended to aid medical professionals to quickly create, understand, and share complex patient anatomy from CT and MRI scans in an “immersive” 3D environment, the company says. The virtual collaboration
Drugs
FDA commissioner Robert Califf says a major reformation of our national system for generating medical evidence — the clinical research enterprise — is needed to facilitate the translation of biomedical research into useful products and interventions. Writing in the journal Clinical Trials, Califf says that currently premarket systems for generating and evaluating
Biologics
FDA has issued Eli Lilly a complete response letter for its accelerated approval BLA submission for donanemab, indicated for treating early symptomatic Alzheimer’s disease. FDA’s rejection letter took issue with the “limited number of patients with at least 12 months of drug exposure data provided in the submission,
Drugs
The Biotechnology Innovation Organization (BIO) recommends ways FDA could strengthen its International Council for Harmonization Q5A draft guidance on evaluating the viral safety of biotechnology products derived from cell lines of human or animal origin. The association’s comment letter recommends that FDA: * clarify the role/conduct of new molecular
Drugs
FDA has denied a 2/2022 citizen petition from advocacy group Public Citizen that urged it and the Drug Enforcement Administration (DEA) to open proceedings to place gabapentin (Almatica Pharma’s Gralise and Pfizer’s Neurontin) and gabapentin enacarbil (Arbor’s Horizant) into Schedule V of the Controlled Substances Act.
Drugs
Merck says it has identified the root cause of nitrosamine (NTTP) formation in certain Januvia (sitagliptin) batches, and it has provided a detailed report to FDA and other health authorities The drug is indicated for treating Type 2 diabetes mellitus. Last year, FDA said it became aware of the nitrosamine
Devices
FDA says it has opened a public docket to receive stakeholder comments on the question of how the agency should use MDUFA 5 user fee funding that may be distributed to an external organization other than the National Evaluation System for Health Technology (NEST). An agency notice says the comment
Biologics
Janssen and its global partners say they are ending the Phase 3 Mosaico HIV vaccine trial following an independent, scheduled data review that found the regimen was not effective in preventing HIV infection compared to a placebo among study participants. A Janssen statement says no safety issues with the vaccine
Drugs
FDA is asking a Texas federal court to deny a request for a preliminary injunction sought by the Alliance for Hippocratic Medicine and others to reverse the FDA 2000 determination that mifepristone is safe and effective for the medical termination of intrauterine pregnancy under certain conditions. FDA’s filing in
Biologics
Moderna says it will seek regulatory approval in the first half of this year for its MRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine for older adults that met its primary endpoints in a Phase 3 trial. A company statement says the successful endpoints included vaccine efficacy of 83.