Drugs
FDA has issued a complete response letter for Zealand Pharma’s dasiglucagon, intended to prevent and treat low blood sugar in children with congenital hyperinsulinism. The Danish drug company says FDA found deficiencies at the firm’s third-party manufacturing facility that are not specific to dasiglucagon. There were no
Drugs
FDA has approved a label update for Kite’s Yescarta (axicabtangene ciloleucel) to include the overall survival primary analysis from the landmark Phase 3 Zuma-7 study that showed a statistically significant improvement for Yescarta in overall survival versus standard of care as second-line treatment with curative intent for
Drugs
FDA says Wipro Unza Singapore Private, Limited, in Winsland House II, Singapore, which is registered with the agency as a manufacturer of over-the-counter drug products, failed to respond to FDA requests for records. A 12/21/2023 Warning Letter says the company failed to respond to two requests
Drugs
FDA has approved Ionis Pharmaceuticals/AstraZeneca’s Wainua (eplontersen) to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. An Ionis news release says the approval was based on the Phase 3 NEURO-TTRansform trial that showed Wainua demonstrated consistent and sustained benefit halting neuropathy disease progression and improving neuropathy
Devices
A 6/6-6/9/2023 FDA inspection at Terragene S.A. in Alvear, Santa Fe, Argentina, determined that the firm manufactures and distributes Biological and Chemical Sterilization Process Indicator Systems that are legally considered to be medical devices. A just-released 11/1/2023 Warning Letter cited these Quality
Drugs
FDA says its review of records submitted by Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi in Avcilar/Istanbul, Turkey, a registered manufacturer of over-the-counter drugs, found significant violations of current good manufacturing practice (CGMP) regulations. A just-released 11/13/2023 Warning Letter says the specific
Drugs
FDA says a 12/5-12/16/2023 Bioresearch Monitoring Program inspection at Siyan Clinical Research, maintained by Anish Shah in Santa Rosa, CA, found objectionable conditions. A 12/12/2023 Warning Letter says Shah failed to ensure that the redacted investigation was conducted according to the investigational plan. “While
Drugs
FDA commissioner Robert Califf says the agency “is already capable of reviewing submissions that include or rely entirely on RWD (real-world data). Enabling advanced data analytics, including RWD, is also incorporated in FDA’s information technology strategy for 2024-2027.” Writing in an FDA Voices Catching Up with Califf
Drugs
FDA has published a guidance, Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drugs and Biological Products, with information about (1) a registry’s fitness for use in regulatory decision-making, focusing on registry attributes that support the collection of relevant and reliable data, (2) linking a
Devices
FDA says ResMed is conducting a voluntary field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. An agency announcement says the company’s masks are safe when used following
Drugs
FDA has published a guidance, Rare Diseases: Considerations for the Development of Drugs and Biological Products, to assist sponsors in conducting efficient and successful development programs for drugs to treat rare diseases. The document notes that while the statutory requirements for marketing approval for drugs to treat rare and common
Drugs
FDA has published a draft guidance, Master Protocols for Drug and Biological Product Development, with recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on submitting documentation to support regulatory review. The document says its primary focus is on randomized umbrella and
Drugs
FDA says it is requiring labeling updates intended to reduce the risk of severe chemical irritation and damage to tissues from intravenous administration of promethazine HCl injection. An agency notice says the injection is indicated to help manage certain allergic reactions, motion sickness, post-operative nausea, and vomiting, and as
Biologics
FDA has published a draft guidance, Potency Assurance for Cellular and Gene Therapy Products, with recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy product. The document says a potency assurance strategy is “a multifaceted approach that
Drugs
FDA says a review of business records and other information on Patco Cosmetics in Mumbai, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished over-the-counter drugs. A just-released 12/15 Warning Letter says the specific violations were: * failing to conduct at least
Drugs
FDA says it is investigating counterfeit copies of Novo Nordisk’s Ozempic (semaglutide) injection 1 mg in the U.S. drug supply chain and has seized thousands of units of the product. An agency announcement says FDA and the company are testing the seized products and do not yet have
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
Devices
FDA says Medline Industries announced 12/20/23 a 10/10/23 recall of several lots of tracheostomy care and cleaning trays that include a tracheostomy brush that may have sharp edges at the tip that can puncture tubing during use and/or cause user injury during handling. An agency
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