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 Issues Final Guidance for ANDA Amendments Under GDUFA II
FDA Issues Final Guidance for ANDA Amendments Under GDUFA II
The FDA released final guidance spelling out its review goals for amendments to abbreviated new drug applications and prior approval supplements under GDUFA II.
To View This Article:
Login
Subscribe To International Pharmaceutical Regulatory Monitor