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.
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 63rdIPC 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!?.
Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals