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 GMP Report
Category Archives: Drug GMP Report
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
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
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
Colorado — one of five states with drug importation plans in the works — has submitted its plan for importing prescription drugs from Canada to HHS for approval.
Source: Drug GMP Report
President Trump has invoked the Defense Production Act in response to the growing coronavirus pandemic, enabling the federal government to order private industry to manufacture emergency medical supplies.
Source: Drug GMP Report