News

The FDA has published a new guidance document on the possible use of alternative methods in the preparation of inspections or in place of inspections for marketing authorisation applications that are still pending.

The FDA recently issued a Warning Letter to a pharmaceutical company in Florida (USA) for violating CGMP regulations and expectations on Quality Oversight.

In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.

In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.