Devices
Dewei Medical Equipment has recalled its DNA/RNA Preservation Kits because the products were distributed to U.S. customers without FDA authorization, clearance, or approval. “This means there is a risk for false negative, false positive, or misinterpretation of results if these products are used to detect SARS-CoV-2
FDA Policy/General
FDA is preparing a manuscript to outline a strategy for getting more diversity into clinical trials, commissioner Robert Califf said 12/7 during a plenary session at the Milken Institute’s Future of Health Summit in Washington, DC. Improving trial diversity is a top focus of the agency, and earlier
Biologics
FDA has amended the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech Covid-19 vaccines for use in children as young as six months. An FDA release says that the Moderna bivalent vaccine is now authorized for use in children aged six months through five years as
Drugs
FDA has asked Oncopeptides to withdraw the accelerated NDA approval for multiple myeloma therapy Pepaxto (melphalan flufenamide) after a confirmatory trial (OCEAN) demonstrated a worse overall survival and failed to verify clinical benefit. The request is more evidence (see earlier story) that the agency is holding industry to timely completion
Drugs
FDA has granted fewer NDA/BLA accelerated approvals this year than the previous five years after FDA began taking steps to tighten the accelerated approval process for drugs, telling sponsors they need to have confirmation studies underway before products are approved under the expedited pathway. An Associated Press report quotes
Drugs
FDA has denied a 6/5/2020 petition submitted by Americans for Homeopathy Choice that asked the agency to approve a regulation proposed in the petition to exempt some homeopathic drugs from premarket review and take other steps. The FDA 12/6 response says the advocacy group had six requests:
Biologics
A 2/9-3/8 FDA inspection at Cryos International in Orlando, FL, identified significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A just-released 10/24 Warning Letter says specific violations were: * failing to test a specimen from an anonymous semen donor
Drugs
FDA has released a final guidance entitled “Homeopathic Drug Products” that describes how the agency intends to prioritize enforcement and regulatory actions for such products marketed without the required FDA approval. The document outlines a risk-based approach for prioritizing enforcement and regulatory actions. For example, the following unapproved homeopathic
Devices
FDA has denied a petition submitted on 12/11/2020 by attorney James Czaban (Loeb & Loeb) asking that the agency “clarify and confirm circumstances … under which garments generally known as ‘scrubs,’ which are worn as daily-wear uniforms by a wide variety of employees in various healthcare settings, are
Drugs
Commenting on FDA’s plans for premarket reviews of safety data and safety signal detection, Pharmaceutical Research and Manufacturers of America (PhRMA) says that while FDA has identified a need for improvement in Medical Dictionary for Regulated Activities (MedDRA) standardized medical queries (SMQ), sponsors conduct clinical trials and execute submission
Devices
CDRH researchers say the medical device shortage early reporting requirements included in the CARES Act facilitated early identification and mitigation of device shortages during the Covid-19 pandemic. Writing in Health Affairs, they say (purchase required) that outside of public health emergencies, the agency does not have the regulatory authority
Drugs
The Coalition for Health AI has released a summary of meetings held by experts across a dozen institutions, with observers from FDA and other stakeholders, working through issues that would need to be addressed for enabling trustworthy artificial intelligence (AI) in healthcare. “This work summarizes those discussions as a step
Biologics
FDA is defending criticism (see earlier story) from three former FDA Team Biologics inspectors who left the agency over working conditions and a lack of training, which they claim leaves the team with inspectors ill-equipped to identify manufacturing quality control issues. The inspectors were granted anonymity for a lengthy
Drugs
A 6/20-6/24 FDA inspection at the AG Hair Limited drug manufacturing facility in Coquitlam, BC, Canada, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. An 11/28 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure
Drugs
A 5/12-5/20 FDA inspection at Glenmark Pharmaceuticals, Bardez, Goa, India, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. An 11/22 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
A 7/5-7/8 FDA inspection at Kari Gran, Inc., in Seattle, WA, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. An 11/30 Warning Letter says specific violations were: * failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory
Drugs
MEI Pharma and Kyowa Kirin have decided to abandon developing PI3K inhibitor zandelisib outside of Japan for B-cell malignancies following FDA input that raised the bar on clinical trial data needed for such an approval. At a meeting with FDA last month, the agency reiterated its recent stance that
Drugs
CDER researchers say the emergence of a variety of drugs to treat or prevent Covid-19 highlighted the need for FDA to move beyond routine pharmacovigilance practices to rapidly identify emerging safety concerns. In an article published in Drug Safety, the researchers report the agency evaluated over 20,000 adverse
Biologics
Three former FDA Team Biologics inspectors who left the agency in recent years due to frustration over working conditions, say needed training for team members has decreased dramatically in recent years, leading to concerns that inspectors are not equipped to identify manufacturing quality control issues. The inspectors were granted anonymity
Devices
Former FDA commissioners Scott Gottlieb and Mark McClellan say Congress should act promptly to approve the Verfiying Accurate Leading-edge IVCT Development Act (VALID Act) and modernize FDA’s regulatory framework for overseeing diagnostic tests that are used to screen blood and tissue. Writing in an online Stat News opinion
Drugs
FDA has released a final guidance entitled “Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer.” The document provides recommendations on the use of pharmacokinetic (PK)-based
Drugs
Contract testing laboratory Valisure has relinquished its regulatory testing ability after a recent FDA inspection raised testing issues associated with the lab, which was behind the identification of several high-profile product safety concerns. The agency has noted that until recently, the company’s Web site offered services including a