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The FDA is amending its color additive regulations to allow for the use of spirulina extract in coating formulations for drug tablets and capsules — giving drugmakers an alternative blue color that is exempt from safety certification requirements. Read More
Allergan has resubmitted its sBLA for Botox, providing the FDA with additional study data on the effects of the injectable drug on lower limb spasticity. Read More
The FDA is seeking input on how it can make its Inactive Ingredients Database more useful and user-friendly, following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More
The FDA has added Chagas disease and neurocysticercosis to the list of treatments for tropical diseases eligible for priority review vouchers, bringing the number to 19. Read More
The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
The FDA has approved the first treatment for sexual desire disorders, Sprout Pharmaceutical’s Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. Read More
CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff. Read More
Amgen agreed Tuesday to pay $71 million to 48 states and the District of Columbia to resolve allegations it promoted biologics Aranesp and Enbrel based on misleading claims. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More