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