Archive for August 2020

The European Medicines Agency (EMA) has issued a proposed five-year pharmaceutical regulatory plan with six areas of focus including improvements in the drug supply chain. Source: Drug GMP Report

As a result of the COVID-19 pandemic, the FDA has extended its enforcement discretion policy for six months for manufacturers of stem cell products to submit marketing applications to the FDA. Source: Drug GMP Report

The FDA released its spring regulatory agenda for proposed and final rulemakings, including the following planned actions: Source: Drug GMP Report

The FDA issued 483s to five drugmakers for inadequate good manufacturing practices observed by agency investigators during inspections of their facilities. Source: Drug GMP Report

Four drugmakers drew warning letters from the FDA for quality failures including testing and other deficiencies. Source: Drug GMP Report

The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling. Source: Drug GMP Report

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continues to extend what it calls temporary “flexibilities” in good manufacturing practice (GMP) to drugmakers to help out with the exceptional circumstances imposed by the current COVID-19 pandemic. Source: Drug GMP Report

FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Source: Drug GMP Report