USFDA guidance for petitioned ANDA [Regulatives / Guidelines]

posted by shahajan baig  – India, 2020-07-20 21:50 (92 d 11:26 ago) – Posting: # 21763
Views: 362

Under the guidance of USFDA "Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry" it is mentioned as:

"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

Regards,

Baig Shahajan

Regards,

SHAHAJAN BAIG

Complete thread:

Activity
 Admin contact
21,170 posts in 4,411 threads, 1,475 registered users;
online 4 (0 registered, 4 guests [including 1 identified bots]).
Forum time: Wednesday 09:17 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5