USFDA guidance for petitioned ANDA [Regulatives / Guidelines]
"A petitioned ANDA is a type of ANDA for a drug product that differs from the RLD in its dosage form, route of administration, strength, or active ingredient (in a product with more than one active ingredient) and for which FDA has determined, in response to a petition submitted under section 505(j)(2)(C) of the FD&C Act (suitability petition), that studies are not necessary to establish the safety and effectiveness of the proposed drug product. A petitioned ANDA is generally expected to provide the same therapeutic effect as the listed drug that was relied on as the basis of the suitability petition."
I want to know that how can suitability petition can be filed without establishing the safety and effectiveness of the proposed drug.
Thanks in advance
- USFDA guidance for petitioned ANDAshahajan baig 2020-07-20 21:50 [Regulatives / Guidelines]