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.
Accept
Home » Drugmakers Seek Clarity on FDA’s CMC Draft Guidance
Drugmakers Seek Clarity on FDA’s CMC Draft Guidance
Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the FDA, saying draft guidance lacks clear criteria and examples.