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The goal of the FDA’s quality metrics program is to share quantitative data with global regulators about the state of manufacturing quality, CDER Director Janet Woodcock said. Read More
Industry is asking the FDA to clarify when immediate-release tablets should be tested using disintegration rather than dissolution and how its draft guidance on dissolution testing meshes with other agency recommendations. Read More
The Federal Trade Commission is taking drugmakers to task for tweaking products to maintain exclusivity and block generic competition, warning the practice — known as product hopping — may violate antitrust laws. Read More
Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April. Read More
Sandoz says the FDA has accepted its second biosimilar application, this one for a copy of Amgen’s autoimmune disease drug Enbrel, whose global sales of nearly $9 billion made it the world’s fifth-biggest selling medicine in 2014. Read More
The FDA Friday granted Merck’s Keytruda accelerated approval to treat advanced non-small cell lung cancer, making it the first PD-1 inhibitor approved for that indication. Read More
A federal judge agreed with the FDA’s interpretation that marketing exclusivity begins with NDA approval — and not the date of controlled substance scheduling — rejecting Eisai’s bid to restore exclusivity for two of its drugs. Read More