The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India. Read More

The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More

The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More

The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Read More

The FDA warned four companies for illegally branding cannabidiol products as treatments for cancer and Alzheimer’s disease. Read More

The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More

The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More

The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More