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…

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.…

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…

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…

FDA investigators found a wide range of GMP deficiencies during inspections of a Biocon facility in India and at four U.S. plants. Source: Drug GMP Report

The FDA sent warning letters to drug manufacturers in India, Korea, China and Denmark for serious violations at their facilities. Source: Drug GMP Report

The FDA said it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Source: Drug GMP Report

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. Source: Drug GMP Report

The FDA has suspended routine domestic and foreign facility inspections in response to the COVID-19 outbreak. Source: Drug GMP Report

The World Health Organization (WHO) is seeking comments by February 28 on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level…