The FDA issued warning letters to two drugmakers and two contract testing facilities for serious quality failures, including testing violations, data integrity lapses and lax environmental monitoring. Source: Drug GMP…
The FDA is working with the Centers for Disease Control and Prevention (CDC) to determine how it will restart routine on-site inspections of drug manufacturing facilities, the agency announced. Source:…
Following considerable public outcry over potential conflicts of interest for government officials who are working on the Trump administration’s initiative to develop COVID-19 treatments and vaccines, Janet Woodcock is temporarily…
Among the many urgent priorities it faces during the pandemic, the FDA is devoting substantial resources to monitoring fraudulent COVID-19 products, issuing two dozen warning letters in May — including,…
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance exempting certain COVID-19 products from tracing and identification requirements. Source: Drug…
The FDA found a range of quality lapses during inspections at eight U.S.-based plants. Source: Drug GMP Report
CDER laid out how it will review newly identified safety signals (NISS) for marketed drugs, in a new Manual of Policies and Procedures (MAPP). Source: Drug GMP Report
The FDA hit online pharmacy Unitedpharmacies.md with a warning letter for marketing on its website unapproved and misbranded products as COVID-19 treatments. Source: Drug GMP Report
The FDA issued a warning letter to an Oregon compounder for lax aseptic practices observed during an inspection of its facility. Source: Drug GMP Report
Pfizer was taken to task in an FDA warning letter over testing violations at its Visakhapatnam, Andhra Pradesh sterile injectable drug facility. Source: Drug GMP Report