Drugs
Researchers say a pilot program using a mixed reality device with a collaborative text messaging system allowed multiple national regulatory authorities, including FDA, to perform a regulatory inspection of a good manufacturing practice (GMP) facility simultaneously, while still following their respective internal procedures. Writing in Therapeutic Innovation & Regulatory Science,
Devices
FDA has withdrawn its membership in the 32-member medical device Global Harmonization Working Party (GHWP), which is chaired by China, after failing to persuade the organization to align with other international harmonization efforts, such as the International Medical Device Regulators Forum (IMDRF). “Moving forward, FDA will spend the next
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled Good Laboratory Practice (GLP) Requirements for Nonclinical Laboratory Studies — 21 CFR Part 58. The collection supports agency regulations that specify minimum standards for the proper conduct of safety testing. They also address facilities, personnel, equipment, standard operating
Devices
Unomedical is recalling certain VariSoft Infusion Sets due to the risk that the device’s connector may detach from the set which would disrupt insulin delivery. “If this occurs, insulin may continue to flow through the tubing that is now disconnected from the patient and the insulin pump would not
Biologics
FDA has accepted for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) autologous COL7A1 gene-corrected epidermal sheets for treating patients with recessive dystrophic epidermolysis bullosa (RDEB). The agency has set a 5/25/2024 review action target date, according to the company, adding that an advisory
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Covid-19: Developing Drugs and Biological Products for Treatment or Prevention.” The document describes FDA’s current recommendations for Phase 2 and Phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical
Drugs
FDA has sent Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treating dry eye disease. The letter said the submission did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled
Drugs
Novartis has recalled two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottles, which could result in incorrect dosing. The issue was identified during an investigation of crystallization in a different Sandimmune lot, according to a recall notice. The drug is
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 10/24 notice on the revised draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” Comments can now be submitted until 1/5/2024.
Biologics
CBER director Peter Marks and CDC National Center for Emerging and Zoonotic Infectious Diseases director Daniel Jernigan say the Vaccine Adverse Event Reporting System (VAERS) their agencies co-manage “works and has a track record that proves it.” The two wrote an online FDA Voices post that “explains how VAERS
Drugs
In an 11/21 brief, FDA urges the Supreme Court to hear an appeal of the 5th Circuit Court of Appeals decision that sharply restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex). The filing says the 5th Circuit’s decision contradicts fundamental principles of Article III of
Drugs
FDA has approved an Evive Biotech BLA for Ryzneuta (efbemalenograstim alfa), indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Approval was based on data from two pivotal Phase 3 Studies, GC-627-04 [NCT02872103] and
Drugs
Entrada Therapeutics says that despite providing additional information to FDA, an ongoing clinical hold against the company’s Phase 1 trial of ENTR-601-44 in Duchenne muscular dystrophy (DMD) patients remain in effect. “Importantly, the information that was submitted to the FDA supported the initiation of the Phase 1
FDA Policy/General
Federal Register notice: FDA has determined that Indivior’s Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Buprenex
Biologics
FDA has published a final guidance, Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, to assist sponsors in developing such products. The document describes the agency’s current recommendations for Phase 2 and 3 trials, with a focus on trial population, trial design, efficacy endpoints, safety considerations,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Translation of GLP Study Reports: Questions and Answers.” The document provides information to sponsors and nonclinical laboratories about study reports being translated from the original language into English, and appropriate documentation to ensure accurate and complete study data are
FDA Policy/General
FDA is declining to take the action sought in an 8/3/2020 petition from Knowledge Ecology International to ban all music during the presentation of risk information in direct-to-consumer ads. In its response, the agency says its current approach includes the assessment of background music in ads,
Devices
FDA has cleared a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use. The company says the watch was developed to be lifestyle-friendly to provide users with “untethered continuous pulse oximetry
Drugs
An eastern California federal grand jury has returned a three-count indictment against Jia Bei Zhu, aka Jesse Zhu, Qiang He, and David He, a citizen of China who formerly resided in Clovis, CA, charging him with distributing adulterated and misbranded medical devices in violation of the federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA is announcing a public workshop entitled “Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice.” The workshop will discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs. It may also serve as the basis of a future a
FDA Policy/General
Federal Register notice: FDA is announcing a 1/23/24/2024 public meeting entitled “Advancing Drug Development for the Prevention of Spontaneous Preterm Birth.” The meeting is intended to gather stakeholder input on the impact of preterm birth on families and on society, as well as on the ethical, regulatory,
FDA Policy/General
Federal Register final rule: FDA is issuing a final rule on direct-to-consumer television and radio advertisements for prescription drugs and a requirement that the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. The rule establishes standards to determine