Archive for May 2020
CDER Issues Staff Manual on the Newly Identified Safety Signal Process
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
Read MoreOnline Pharmacy Warned for Selling Unapproved COVID-19 Products
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
Read MoreOregon Compounder Hit for Poor Aseptic Practices
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
Read MoreFDA Hits Pfizer Facility in India for Shoddy Sterility Testing
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
Read MoreEMA Creates New Drug Shortage Reporting System
The European Medicines Agency has introduced a new system for reporting drug shortages and potential supply chain disruptions as the COVID-19 pandemic takes a toll on the stock of some critical medicines. Source: Drug GMP Report
Read MoreEMA Recommends Extending GMP Certificates Until End of 2021
The European Medicines Agency (EMA) recommended that good manufacturing practice (GMP) certificates for drugmakers be extended until the end of 2021 to avoid potential drug supply-chain disruptions during the pandemic. Source: Drug GMP Report
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