Updated Q&A Document on the Submission of Variations published
The CMDh updates irregularly a Q&A document about the difficulties concerning the submission of variations applications and the classification of changes according to the new "Variations Regulation" (EC) 1234/2008. An updated Q&A document has been recently published. Read more here
The number of Warning Letters issued to Drug Companies and API Manufacturers increases
The number of Warning Letters the FDA issued to drug companies and API manufacturers last year has heavily increased. Some European companies are to be found among the addressees. A systematic analysis shows that most of the frequent deviations have been the same since four years. Read more here.
New FDA Guidance: Codevelopment of Investigational Drugs for Use in Combination
FDA's Center for Drug Evaluation and Research (CDER) has published a Guidance for Industry on the codevelopment of two or more novel drugs to be used in combination to treat a disease or condition. Read more.