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As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More
The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More
Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what sponsors must do to ensure that their agreements with CMOs are clear and enforceable. Read More
The U.S. government and life sciences industry groups have asked Japan not to change the country’s drug pricing system to annual price reviews and cuts, instead of the current two-year review. Read More
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 French government broadened its legal definition of biomedical research to all research involving humans, including observational studies. Read More
As of the end of fiscal 2015, postmarket requirements were fulfilled for 69 percent of NDAs, marking a slight decline from the previous fiscal year. Read More