Special Protocol Agreement Fda

Section 119 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) amended Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 355(b)) and asked the FDA to meet with sponsors who, provided certain conditions are met, are able to reach agreement on the design and scope of well-controlled clinical trials; which must be the primary basis for proof of the effectiveness of marketing in accordance with Section 505(b) of the FD&C Act or Section 351 of the Public Health Services Act (PHS Act) (42 U.S.C 262). These provisions were then amended in Section 7002(d)(1) of the Bioologics Price Competitiveness and Innovation Act 2009, to include any clinical studies or studies necessary for biosimilar applications of biologics, pursuant to Section 351(k) of the PHS Act. In accordance with Section 505(b)(5)(B) of the FD&C Act, the objectives of the PDUFA and the BsUFA objectives, the following protocols are suitable for THE SPA: (1) animal carcinogenicity protocols; (2) drug and drug stability protocols; 3. animal efficacy protocols for studies intended to demonstrate in the first place the efficacy necessary for the authorisation or authorisation of products produced in accordance with the animal rule; (4) test reports which are to form the main basis of a claim for efficacy; and (5) clinical trials necessary to establish bio-resemblance and/or interchangeability. The path to a successful SPA involves thorough preparation and smooth execution. Camargo has extensive experience in developing successful spa agreements with the FDA and can help deal with the uncertainty associated with SPAs.