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Pfizer was taken to task in an FDA warning letter over testing violations at its Visakhapatnam, Andhra Pradesh sterile injectable drug facility. Read More
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. Read More
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. Read More
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. Read More
Sponsors who fail to meet certain Risk Evaluation and Mitigation Strategy (REMS) requirements won’t face FDA action during the COVID-19 outbreak, the agency announced. Read More
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. Read More
Manufacturers need to provide two-week updates on any supply issues during the COVID-19 emergency and going forward, the FDA said in a new straight-to-final guidance. Read More