Drugs
FDA has granted Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181), assays that measure two Alzheimer’s Disease biomarkers — beta-amyloid and tau proteins — in adults aged 55 years and older. The company says the assays achieve
Drugs
FDA is seeking feedback on a discussion paper entitled Distributed Manufacturing and Point-of-Care Manufacturing of Drugs that presents areas the agency has identified for consideration while it evaluates the existing risk-based regulatory framework as it applies to those technologies. The agency says the discussion paper “considers relevant
Drugs
Federal Register notice: FDA is withdrawing approval of 35 NDAs from multiple applicants who requested this action because the the drugs were no longer marketed. To view the notice, click here.
Drugs
FDA and other members of the International Conference on Harmonization have adopted a guidance entitled “Continuous Manufacturing of Drug Substances and Drug Products Q13.” The document describes scientific and regulatory considerations for developing and operating continuous manfucturing (CM), which it defines as involving the “continuous feeding of input materials into,
Drugs
FDA has released the form FDA-483 issued following an 11/10-11/18 inspection at the Aurobindo Pharma Unit IX active pharmaceutical ingredient (API) intermediate manufacturing facility in Telangana, India. The form’s 10 inspection observations were: * out-of-specification and complaint investigations for API intermediate products are deficient;
Drugs
FDA has released the form FDA-483 issued following an 11/13-11/21 inspection at the Lupin Unit 1 drug manufacturing facility in Pradesh, India. The form contains these 16 inspection observations: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Drugs
FDA is issuing a proposed rule to replace the current investigational new drug (IND) annual reporting requirement with a new FDA Development Safety Update Report (DSUR). The proposal says the agency currently requires sponsors to submit an annual report with information about each ongoing study related to the IND, and
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biological products, will “help improve the collection of clinical pharmacology information, such as pharmacokinetics and pharmacodynamics data, to better inform dose selection and individualization in the pediatric
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:
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
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
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
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
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
Drugs
FDA has sent Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold placed 11/4 (see story) on VERVE-101 and a study in patients with heterozygous familial hypercholesterolemia. The agency is requesting additional preclinical data related to: (1) potency differences between human