GMP News - Pharmaceutical Development / Clinical Trials / GCP


Warning Letters Report 2010: Laboratory Controls and Analytical Methods again among Top Five GMP Deviations

The analysis of FDA's Warning Letters from fiscal year 2010 shows growing deviations in Laboratories. Unadapted analytical methods and missing documentation keep on increasing. Read more here.



ICH Q8, Q9 und Q10: new Q&A Document published

The ICH Quality Implementation Working Group (Q-IWG) has issued volume 4 of the ICH guideline Q8, Q9 and Q10 - Questions and Answers Document. Read more.



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.



FDA issues Guidance on Public Comment Procedures at Advisory Committee Meetings

The FDA has issued a final guidance for people who wish to comment during the agency’s advisory committee meetings. Read more.


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