Norlase Gets CE Mark for Leaf Laser
The Leaf received 510(k) clearance from the FDA in October 2019. Source: Devices & Diagnostics Letter
Apotex Subsidiary Signa Gets FDA Warning Letter
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…
Fort Worth OTC Maker Written Up for Lack of Testing
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 TGA Re-Tests COVID-19 Antibody Tests
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
483 Roundup: Three Firms Cited for Quality Failures
The FDA hit three device facilities with 483s for quality violations observed during agency inspections. Source: The GMP Letter
Warning Letter Roundup: FDA Warns Six Firms for Serious Violations
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 FDAer Says Allowing Developers to Self-Validate COVID-19 Tests Led to Chaos
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…
FDA Delays Certain UDI Requirements During Pandemic
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 Pushes for Boxed Warning on Type 2 Diabetes Drugs
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
FDA Outlines GMPs for COVID-19 Infections in Workers
The FDA has released guidance for drugmakers on good manufacturing practices (GMPs) for responding to COVID-19 infection in employees. Source: Drug GMP Report
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