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.
CDER plans to start using a new informatics platform for new drug approvals in October, following the processes already in place for generic drug reviews, says CDER Director Janet Woodcock. Read More
Over four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances. Read More
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More
An early OMB blueprint for the president’s fiscal 2018 budget request looks to transfer $54 billion from non-defense programs and agencies, including the FDA, to the military. Read More