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
Devices
FDA says a 6/26-8/2/2023 inspection at the Fresenius Medical Care Holdings facility in Waltham, MA, found Quality System regulation violations in the facility’s work as medical device specification developer responsible for complaint handling, recall management, and quality system oversight of the firm’s North American
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
FDA Policy/General
FDA has published a guidance, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers, to help small entities understand and comply with the standards established in that final rule.
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
Devices
FDA has approved AutoGenomics’ AvertD, the first test that uses DNA to assess whether certain individuals may have an increased risk of developing opioid use disorder. CDRH director Jeffrey Shuren says the AvertD test is intended to be used before the first exposure to oral opioid pain medications in patients
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
Devices
FDA has published a draft guidance, 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. The document says FDA may contract with third-party review organizations to perform reviews of emergency use authorization (EUA) requests when appropriate emergency declaration authorities are active. The guidance says
Devices
FDA says CDRH has begun issuing electronic export documents for medical devices. “The change from paper to electronic PDF improves efficiency in issuing export documents, reduces the amount of time it takes for a manufacturer to receive export documents, and decreases the environmental burden,” an agency notice says. The notice
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
FDA Policy/General
FDA Webview has summarized below the Federal Register notices published during our holiday break. 12/28/2023 Federal Register notice: FDA is making available a draft guidance entitled “Potency Assurance for Cellular and Gene Therapy Products.” The document provides quality risk management recommendations to help assure the potency of human
Devices
A lengthy, deeply-researched KFF Health News report into its year-long investigation of FDA efforts to determine the safety and effectiveness of medical devices approved through the 510(k) pathway says they found “deep flaws” in FDA activities that resulted in “patient harm, exposed in lawsuits and records.” The
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
Devices
A 6/5-6/7/2023 FDA inspection at Sonesta Medical AB in Solna, Sweden, found Quality System Regulation violations in the firm’s manufacturing of a radiographic table and two cystometric tables. A just-released 9/22/2023 Warning Letter says the specific violations were failing to establish and