Drugs
FDA commissioner Robert Califf used an FDA Voices Catching Up with Califf column to discuss the agency’s work to harmonize clinical research regulations and facilitate the development of medical products to benefit public health. In the column, he writes that FDA has taken several steps to advance clinical research
Drugs
FDA has published a draft guidance, Quality Considerations for Topical Ophthalmic Drug Products, with quality considerations for gels, ointments, and liquid formulations. The document specifically discusses: * microbiological considerations; * approaches for evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; * the use of in vitro drug release/dissolution
Drugs
A 7/24-7/28/2023 FDA inspection at the Omeza drug manufacturing facility in Sarasota, FL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/12/2023 Warning Letter says specific violations were: * failing to maintain the buildings used in the manufacture, processing,
Drugs
FDA has issued a complete response letter saying that Merck’s NDA resubmission for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough. A company statement says the letter was not related to
Drugs
FDA says Insight Pharmaceuticals is recalling one lot of Americaine 20% benzocaine topical anesthetic spray. An agency notice says that while benzene is not an ingredient in any of the Americaine topical spray products, the manufacturer and its third-party laboratory found that a sample from one lot of the
Drugs
FDA says its review of a Web site maintained by Hua Da Trading in Brooklyn, NY, determined the firm takes orders for its “WeFun” product which is considered by FDA to be an unapproved and misbranded drug, even though the firm markets it as a dietary supplement. A 12/20/
Drugs
FDA says Hospira has recalled one lot of bleomycin for injection, USP 15 units single dose Onco-Tain glass fliptop vial, due to a confirmed customer report for the presence of glass particulate within a single vial. The agency notice says that to date no adverse event reports related to
Drugs
FDA says its review of Web sites and social media sites maintained by East Fork Cultivars in Takilma, OR, determined the company takes orders for products that are promoted as containing cannabidiol. A 12/22/2023 Warning Letter says that claims on the Web sites establish that the products are
Drugs
A 7/10-7/18/2023 FDA inspection at the Dextrum Laboratories drug manufacturing facility in Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/7/2023 Warning Letter says specific violations were: * failing to conduct at least one test
Drugs
FDA has approved an updated Boxed Warning about secondary cancers for Janssen/Legend Biotech’s Carvykti (ciltacabtagene autoleucel). The approval is for a new item in the Boxed Warning stating that “secondary hematological malignancies, including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), have occurred following treatment with Carvykti.” The
Drugs
FDA has published an immediately effective guidance, Reformulating Drug Products That Contain Carbomers Manufactured With Benzene, with recommendations for applicants and manufacturers on the tests that should be performed and the documentation that should be submitted or available to FDA to support the reformulation of drug products that use carbomers
Drugs
FDA says Hospira has recalled one lot each of its 4.2% sodium bicarbonate injection, 8.4% sodium bicarbonate injection, and atropine sulfate injection due to the potential presence of glass particulate matter. An agency notice says the potential for glass particulate matter was identified during product inspection. Hospira says
Drugs
FDA says its review of a Web site maintained by Botanical Be in El Paso, TX, found that the company is taking orders for several products labeled as dietary supplements that legally are considered to be misbranded, unapproved new drugs. A 12/21/2023 Warning Letter says the products contain
Drugs
FDA had 10 observations in its 12/11-12/22/2023 pre-approval inspection at Aurobindo Pharma’s new injectable facility in East Windsor, NJ. India’s Business Standard reports the company said in a regulatory filing that the observations were “procedural” and would be addressed within the stipulated time.
Drugs
FDA has published an immediately effective guidance, Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization, with recommendations for sponsors on developing monoclonal antibody products intended to prevent or treat Covid-19, including recommendations on addressing the impact of emerging variants. The document says that while
Drugs
FDA says Amazon’s fulfillment service, provided to third-party vendors, is illegally distributing several energy enhancement dietary supplements or food that contain undeclared erectile dysfunction drugs. A 12/20/2023 Warning Letter says laboratory analyses found the products contain either sildenafil (the Viagra active ingredient) or tadalafil (the Cialis
Drugs
A 7/24-8/3/2023 FDA inspection at the Inopak drug manufacturing facility in Ringwood, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/15/2023 Warning Letter says specific violations were: * failing to establish an adequate quality unit and
Drugs
FDA has placed a clinical hold on Iovance Biotherapeutics’ IOV-LUN-202 clinical trial, which is assessing LN-145 tumor infiltrating lymphocyte (TIL) therapy in non-small cell lung cancer (NSCLC), in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion
Drugs
A 4/4-4/12/2023 FDA inspection at the Colonial Dames drug manufacturing facility in Commerce, CA, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/5/2023 Warning Letter says specific drug adulteration violations were: * failing to establish adequate
Drugs
FDA has issued a complete response letter for the Amgen sNDA that sought full approval for its Lumakras (sotorasib). The company says the agency’s review was based on the CodeBreak 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-
Drugs
FDA has approved a Merck NDA for Welireg (belzutifan) for treating patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Approval was based on data
Drugs
FDA has approved a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reducing intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. The product is designed to deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside