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The FDA intends to review 90 percent of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter. Read More
A former Valeant executive has been charged and arrested for allegedly defrauding the company of millions by discouraging business with other pharmacies besides Philidor, and convincing it to agree to an option to purchase the specialty pharmacy. Read More
Oxygen and nitrogen were added to the list of medical gases subject to conditional label exemptions, while cyclopropane and ethylene were removed, according to a final rule from the FDA. 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
House Republicans have asked all federal agencies to postpone rulemaking until President-elect Donald Trump’s administration and the newly elected Congress assume office next year. Read More
The EMA Management Board has advanced the development of a web portal that will provide free information on European medicines across the products’ lifecycle. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More