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