Archive for July 2020
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 Daily
Read MoreAustralia’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
Read More483 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
Read MoreWarning 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
Read MoreFormer 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 products on the market. Source: The GMP Letter
Read MoreFDA 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 Letter
Read MorePublic 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
Read MoreFDA 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
Read MoreUSP Supports Use of Crab-Derived Reagents for Drug Tests
After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Source: Drug GMP Report
Read MoreNabriva Hit With a Second Complete Response Letter for Antibiotic
Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or efficacy. Source: Drug GMP Report
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