We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Merck is recalling thousands of bottles of Temodar and temozolomide capsules, because cracks in the caps have rendered the child-resistant closure ineffective. Read More
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