Examples of FD&C Act in a sentence
The products do not fail to conform to a tobacco product standard in effect under Section 907 of the FD&C Act.
See section 745A(a) of the FD&C Act and FDA guidance for industry Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (745A(a) Implementation Guidance).
Section 737(1) of the FD&C Act includes product development protocols within the definition of premarket applications subject to user fees.
Insofar as this41 guidance specifies the format for electronic submissions pursuant to section 745A(a) of the42 FD&C Act, it will have binding effect.
If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent to: Jessica Mu, Director of Compliance Branch at oradevices3firmresponse@fda.hhs.gov.