GMP News Drug Safety/Pharmacovigilance

Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.

With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.

The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.

The ICH E11A draft reached Step 2 of the ICH process. The guideline describes the extrapolation framework consisting of the pediatric extrapolation concept and the pediatric extrapolation plan.

The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.

The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.