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 » FDA Clarifies Scope of Major Deficiencies in ANDA Refuse-to-Receive Guidance
FDA Clarifies Scope of Major Deficiencies in ANDA Refuse-to-Receive Guidance
The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry.