Tag: Program

By - SebastianFeye

New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023

In September of 2018, the FDA took their first step to improve and modernize the process of a 510(k) electronic submission. This commitment was established as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) that was enacted on July 9, 2012, amending the FD&C Act by adding section 745A. As part of this Act, a program

Tagged : device, eCopy, electronic, FDA, Guidance, Health Canada, medical, modernization, PDF, Pilot, premarket, process, Program, submission

By - SebastianFeye

2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

Updated: March 26, 2021 – FDA has stated that MDF facility fees will be $20,322, and CMO facility fees will be $13,548. Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and

Tagged : Adminstration, CARES Act, drug, drugs, FDA, Food, Food and Drug Administration, GRASE, Medicine, monograph, OMOR, OTC Monograph Order Request, Over-the-counter, Program, reform, User fees

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Tag: Program

New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023

2020 Over-the-Counter (OTC) Drug Monographs Reform Summary