Gilead Sciences said it is buying a 49.9 percent stake in Tizona Therapeutics, a company developing first-in-class cancer immunotherapies, for $300 million in a transaction expected to close in the…
Signa, a Mexican subsidiary of Canadian generic drugmaker Apotex, has received an FDA warning letter for failure to correct manufacturing problems for active pharmaceutical ingredients (API) that were later released…
The FDA has slapped Eosera with a Form 483 after finding the over-the-counter (OTC) ear-care product manufacturer failed to validate drug products and properly investigate bacterial contamination. Source: Drug Industry…
Australia’s Therapeutic Goods Administration (TGA) said it is reviewing all approved serology-based COVID-19 point-of-care tests to verify their ability to detect SARS-COV-2 antibodies. Source: The GMP Letter
The FDA hit three device facilities with 483s for quality violations observed during agency inspections. Source: The GMP Letter
The FDA sent warning letters to six device companies for violations including missing documents, design validations, and other compliance lapses. Source: The GMP Letter
Former FDA Chief Scientist Jesse Goodman told a House subcommittee hearing that the FDA’s decision to allow diagnostic test developers to self-validate their COVID-19 products caused a flood of unqualified…
The FDA announced that it will delay enforcement of new requirements for unique device identification (UDI) on class I and unclassified medical devices until Sept. 24, 2022. Source: The GMP…
Public Citizen has petitioned the FDA to require a black box warning for sodium-glucose cotransporter-2 (SGLT2) inhibitors used off-label for treatment of type 1 diabetes. Source: Drug GMP Report
The FDA has released guidance for drugmakers on good manufacturing practices (GMPs) for responding to COVID-19 infection in employees. Source: Drug GMP Report