This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Regulatory strategy for filing NDA/ANDA
Corresponding Author(s) : Miryala Aishwarya
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
In Pharmaceutical Industry, Regulatory Affairs Department makes an interface between the regulatory authorities and pharmaceutical industry. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the inter phase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorized medicinal products. This professional can play a key role in guiding drug development strategy in an increasingly global environment and has an important role for submitting the newly discovered drug products approval documents to the US FDA regulatory authorities and to carry out all the practices required for obtaining the drug products approval. This article mainly focuses on the US FDA drug approval strategies. These strategies playing core job in the pharmaceutical industry. These strategies having all the guidelines which are indispensable part of the IND, NDA and ANDA drug approval applications. It plays a significant role in sequence for registration of newly exposed products and also providing the guidelines which is helpful preparing the registration documents to regulatory authorities.
- Burton, Thomas M. (7 September 2017). "FDA Modernizing Evaluations as Gene, Cell Therapy Fields Grow". Wall Street Journal – via www.wsj.com.
- https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/investigational-new-drug-applications-inds-cber-regulated products#:~:text=An%20Investigational%20New%20Drug%20Application,or%20biological%20product%20to%20humans.
- “IND, NDA, ANDA, Concept of Para I to IV, Exclusivity: Content, Format & Application” http://pharmaquest.weebly.com/uploads/9/9/4/2/994291 6/3.pdf.
- http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformatin/ guidances/ucm400630.pdf
Burton, Thomas M. (7 September 2017). "FDA Modernizing Evaluations as Gene, Cell Therapy Fields Grow". Wall Street Journal – via www.wsj.com.
“IND, NDA, ANDA, Concept of Para I to IV, Exclusivity: Content, Format & Application” http://pharmaquest.weebly.com/uploads/9/9/4/2/994291 6/3.pdf.