Drugs
GSK has stopped enrollment early due to positive results in two Phase 3 trials evaluating gepotidacin, an investigational drug for uncomplicated urinary tract infection (uUTI). The early stoppage comes on the recommendation of an independent data monitoring committee, which conducted a pre-specified interim analysis of efficacy and safety data
Drugs
The FDA Health Informatics Team, the National Institutes of Health Center for Advancing Translational Sciences, and the European Medicines Agency have collaborated to create the Global Substance Registration System (GSRS). An FDA Global Update says the new system will enable the efficient and accurate exchange of information on the substances
Drugs
FDA has published a guidance, Cross Labeling Oncology Drugs in Combination Regimen, with the agency’s current recommendations about including relevant information in the labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of the drugs. The document says a combination regimen
Devices
FDA says the Teleflex 8/26 recall of 60,000 Iso-Gard Filter S products is Class 1. An agency notice says the breathing circuit bacterial filters are connected to respiratory equipment or breathing systems in intensive care units and operating rooms. The recalled units were distributed between 9/1/
Drugs
FDA says it is temporarily exercising additional enforcement discretion for certain clozapine REMS requirements to ensure continuity of care for patients taking the drug. An agency notice says FDA is aware that healthcare professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with access
Drugs
The Department of Justice (DoJ) says an Ohio doctor and a former drug company representative have each pleaded guilty to one count of conspiracy to solicit, receive, offer, and pay healthcare kickbacks. A department statement says Deepak Raheja, Hudson, OH, a doctor specializing in psychiatry and neurology with a practice
Drugs
Radius Health has submitted a supplement to its 4/22 petition regarding its Tymlos (abaloparatide) injection. The supplement asks that FDA take these actions, in addition to those requested in the original petition: * refuse to grant an A-therapeutic equivalence rating to any ANDA or 505(b)(2) NDA referencing
Devices
Cardiac surgeon Hooman Noorchashm, known to FDA for his opposition to power morcellation, has petitioned the agency asking it to change the classification of Becton Dickinson’s (BD) poly 4-hydroxybutyrate (P4HB)-based Phasix and GalaFlex products from medical devices to biologicals so that they undergo proper clinical safety and
Drugs
Six Republican lawmakers are urging FDA commissioner Robert Califf to update them about an ongoing delay to review Florida’s proposed Canadian Prescription Drug Importation Program. A rule advanced by the Trump Administration allows states to implement import programs as long as FDA approves their programs. Florida’s Agency for
Drugs
Eli Lilly says it appreciates FDA’s efforts to better standardize safety data and analysis. Commenting on an agency docket on Advancing Premarket Safety Analytics, Lilly asks that the agency “support efforts in ensuring the document describes a customized approach, which may bring the necessity for updating some terms with
Drugs
An FDA 10/28 Warning Letter says Amazon.com, Seattle, WA, is distributing three products that violate the Federal Food, Drug, and Cosmetic Act. The letter says the firm is responsible for introducing the unapproved drugs into interstate commerce through the Fulfillment by Amazon service. The letter gives examples of
Drugs
A 4/13-4/22 FDA inspection at Sovereign Pharmaceuticals, Fort Worth, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A 10/5 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and process controls designed
Drugs
The Biotechnology Innovation Organization (BIO) says it appreciates that a draft guidance developed by the International Council for Harmonization (ICH) explains how pediatric extrapolation can be applied practically to support the safety and efficacy of a product in pediatric populations in a manner that will advance pediatric drug development globally.
Drugs
FDA has issued a revised draft guidance, Expanded Access to Investigational Drugs for Treatment Use Questions and Answers, with updated information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of the agency’s regulations on expanded access to investigational drugs for treatment use under an
Drugs
A 10/28 citizen petition submitted by the Hyman, Phelps & McNamara law firm asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or Tc-99m product that relies on neutron capture technology given the advances in Tc-99m production that
Drugs
A 3/22-4/4 FDA inspection at the Lupin Limited drug manufacturing facility in Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 9/27 Warning Letter says the specific deviations were: * failing to establish adequate written procedures
Drugs
FDA researchers say the use of expedited drug development and review programs increased from 2008 to 2021 and is likely to continue increasing. Writing in a JAMA Network open-access article, the researchers say they wanted to learn how often the accelerated approval, breakthrough therapy, fast track, and priority review
Drugs
FDA has deferred action on an Amicus Therapeutics BLA for cipaglucosidase alfa, the biological component of AT-GAA in late-onset Pompe disease, due to the agency’s inability to conduct a required manufacturing site inspection in China before the PDUFA action date. A company announcement says the inability to
Drugs
Pfizer says it will file by year end a BLA for its investigational bivalent respiratory syncytial virus (RSV) vaccine after stopping enrollment in a Phase 3 study that it says showed favorable results. In the study, the vaccine was administered to pregnant participants to protect their infants from RSV after
Drugs
FDA has released a final guidance, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonization; Guidance for Industry,” which outlines a “weight of evidence” approach for assessing human carcinogenic risk in drugs. The International Council for Harmonization document is part of FDA’s and other
Devices
FDA has revised the authorized uses for, and is requiring updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests. An 11/1 revised “Letter of Authorization” creates one additional Condition of Authorization and also eliminates an earlier condition that it says
Drugs
FDA has released a draft guidance entitled “Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials.” The document provides recommendations on the most appropriate methods for measuring and recording growth and evaluating pubertal development for evaluating safety. The agency notes that it does not address use of growth or