Search Results for OTC Monograph

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Congress Takes First Look at User Fee Program for OTC Drugs By Michael Mezher - Published 13 September 2017

The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products.

Categories: News, US, FDA, Over the counter drugs

Tags: OTC Monograph, OMOR, Over-the-Counter Monograph, User Fees

FDA Details Draft Goals for OTC Monograph User Fee Program By Michael Mezher - Published 01 August 2017

After a series of discussions with industry and a public meeting in June 2016, the US Food and Drug Administration (FDA) last week released its draft goals letter for the proposed over-the-counter (OTC) monograph user fee program.

Categories: News, US, FDA, Over the counter drugs

Tags: OTC Monograph, User Fees, OMUFA

FDA Considers New User Fee Program for OTC Drugs By Zachary Brennan - Published 10 May 2016

The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Government affairs

Tags: OTC monograph, FDA user fee programs, decongestants, over the counter cough medicines