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The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018. Read More
Taking into account industry criticism, the FDA has loosened the data requirements that drugmakers will have to meet to determine the admissibility of imports entering the U.S. Read More
The European Medicines Agency published new guidance on whether less comprehensive data can be used to support a new indication for a previously approved orphan drug product. Read More
The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data integrity. The amendment to its E6 guideline will now be implemented by ICH members through national and regional guidance. Read More
The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data integrity. The amendment to its E6 guideline will now be implemented by ICH members through national and regional guidance. Read More
The FDA is now directing sponsors to international guideline recommendations for the durations of general toxicity studies that evaluate the direct dosing of drug metabolites. Read More
The European Medicines Agency broadened the scope of its first-in-human trials guidelines, accounting for advancements in clinical trials protocols and complex dose-escalation studies. Read More
The U.S. Supreme Court has refused to hear a case on whether biosimilar makers must wait six months after receiving FDA approval to bring a product to market. Read More
Manufacturers of investigational new drugs intended for research, teaching or chemical analysis do not have to register their establishments with the FDA, according to a revised final rule on the electronic registration of foreign and domestic facilities. Read More