The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Source: Drug GMP Report
Two Indian drugmakers risk losing their EU marketing certificates this month after regulators in France and Croatia turned up a multitude of GMP violations. Source: Drug GMP Report
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Source: Drug GMP…
Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director…
British inspectors turned up a laundry list of apparent violations at two Indian manufacturers, leading them to block drugs from one of them and impose restrictions on the other’s GMP…
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP…
Shortly after receiving an FDA warning letter for alleged major quality deficiencies, an Indian vaccine maker was slammed for data integrity issues and GMP violations by the World Health Organization.…
The FDA has slammed two Indian drugmakers — Emcure Pharmaceuticals and Lupin —for purported GMP violations. Source: Drug GMP Report
Four supplement makers were hit with FDA warning letters March 22 over alleged quality control violations and related issues. Source: Drug GMP Report
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Source: Drug GMP Report