JAN-JUN/JUL-DEC 2020 ISSUE
APP Scientific Updates 2020;8(1-2)
FDA’S “505” REGULATIONS FOR PRODUCT APPROVAL: HOW 505(B) 2 IS A UNIQUE PATHWAY ?
Dahiya S*
Department of Pharmaceutical Sciences
Pharmaceutical Research, Development and Processing Laboratory
School of Pharmacy, University of Puerto Rico-Medical Sciences Campus, San Juan, PR, USA
[email protected]
Determining the right approval pathway is crucial for successful approval of a new drug or a new drug product. This article briefly discusses the types of regulatory pathways for FDA approval of the new drug or new product along with significant differences among each type.
Keywords: FDA regulatory pathways, NDA, ANDA, 505(b)2, Hybrid pathway
APP Sci. Updates
2020; Vol. 8, No. 1-2, A1-A3.
(Received: Dec 07, 2020 / Accepted: Dec 28, 2020)
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