aNDA suitability petition vs. 505 (B) 2 applications

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Pandya Hardik P

Posters: Pharmaceut Reg Affairs

Abstract :

Two routes are well known for filing the variation from the approved RLD as a generic player in the US market that is, filing an Abbreviated New Drug Application (aNDA) following the approval of Suitability Petition (SP) filing and another is filing New Drug Application (NDA) inline with 505(b)(2) of the act. The SP process is addressed in 21 CFR part 10.20 and 10.30, 314.54, 314.93. Most of the times it become confusing in selecting the appropriate route of filing and evaluating their common and uncommon requirements. Underlining information in this article helps in understating the filing requirement of each route and the way in which the US Food and Drug Administration (FDA) has recently begun using its authority for variations is critical for choosing the appropriate path. The differences between the SP and the 505(b)(2) NDA submission are also discussed in FDA.

Biography :

Pandya Hardik P.is currently pursuing his 2nd year M. Pharm in Regulatory Affairs from JSS University, Mysore. He has done his graduation from KLE?s college of pharmacy Belgaum. He has attended 63rd IPC and presented a poster on ?Regulatory Requirements for approval of a new drug in India under Section 122-E? and also attended Indo-American Pharmaceutical Regulatory Symposium- 2011 and presented a poster on ?NewAdverseevent reporting policy by FDA during clinical trials: obliging an eloquent practice!?