Drugs
FDA has granted accelerated approval to Mirati Therapeutics on its NDA for Krazati (adagrasib), a RAS GTPase family inhibitor for treating adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. This is determined by simultaneously approved companion diagnostics — Qiagen’s therascreen KRAS RGQ PCR
Drugs
FDA has notified Iceland’s Alvotech that the new BsUFA goal decision date for the company’s BLA for AVT02, a Humira biosimilar, is 4/13. Alvotech says the notification indicated that the agency has completed its review of the BLA and confirmed that the data provided are sufficient to
Drugs
Celltrion USA says it has submitted to FDA a BLA for its CT-P13, a novel subcutaneous formulation of infliximab to be used as maintenance therapy in patients with moderately to severely active ulcerative colitis and Crohn’s disease. A company statement says CT-P13 is the only infliximab to
Devices
A 3/3/22-3/25/22 FDA inspection at Empowered Diagnostics, Pompano Beach, FL, found that the firm manufactures and distributes several Covid-19 tests that have not received marketing approval, clearance, or authorization from FDA. A just-released 10/6/22 Warning Letter said some of the kits
Drugs
FDA has accepted for review a Pfizer NDA for etrasimod for individuals living with moderately to severely active ulcerative colitis. A company statement says an FDA decision is expected in the second half of 2023. Etrasimod is described as an oral, once daily, selective sphingosine-1-phosphate (S1P) receptor modulator
Drugs
FDA says samples of the SnoreStop NasoSpray, a homeopathic product it obtained from Green Pharmaceuticals, Camarillo, CA, were adulterated because they consisted in whole or in part of a filthy, putrid, or decomposed substance. A 12/16/22 Warning Letter says the firm is registered with FDA as an over-
Drugs
Madrigal Pharmaceuticals says its resmetirom, a liver-directed selective thyroid hormone receptor agonist, met both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for treating nonalcoholic steatohepatitis (NASH) with liver fibrosis. A company statement reported results from the pivotal Phase
Drugs
Rep. Abigail Spanberger (D-VA) has called on FDA and the Drug Enforcement Agency (DEA) to initiate a comprehensive federal response to alleviate the nationwide shortage of prescription Adderall (amphetamine mixed salts) and ensure access to the medication. In a statement (includes letter to agencies), Spanberger says Congress relaxed restrictions
Drugs
Two 12/8 JAMA viewpoint articles examine potential tweaks to FDA’s accelerated approval program to make it easier for the agency to pull an approval if a confirmatory study does not demonstrate clinical benefit. One article, authored by Harvard Law School’s Daniel G. Aaron and I. Glenn Cohen,
Devices
Remel is recalling (Class 1) Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with the following antibiotics: Carbapenem (doripenem, ertapenem, meropenem, imipenem), cefepime, piperacillin/tazobactam, and aztreonam. The in
Biologics
Janssen Pharmaceutical has submitted a BLA for talquetamab for treating patients with relapsed or refractory multiple myeloma. The bispecific T-cell engager antibody is designed to target both GPRC5D, a novel drug target that is on some normal cells but overexpressed on myeloma cells, and CD3 on T cells, according
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;
Devices
FDA has published “Report on Risks and Benefits to Health of Non-Device Software Functions — December 2022.” An agency notice says the report “highlights FDA’s Digital Center of Excellence findings on the five software functions excluded from the device definition by the 21st Century Cures Act.” The functions range
Devices
FDA has published a draft guidance, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers, to help manufacturers better understand and use the VMSR program. The document says it is to further explain, but not change, the conditions of the VMSR program. The guidance describes and clarifies several aspects of the
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
Devices
FDA has published a draft guidance, Content of Human Factors Information in Medical Device Marketing Submissions, with recommendations for the content of human factor and usability engineering information to be included in marketing submissions. The document says a marketing submission should, where appropriate, demonstrate that the needs of the intended
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