Search Results for OTC Monograph

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Public Citizen Sues FDA Over OTC Drug Risks By Michael Mezher - Published 21 September 2017

Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine.

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

Tags: Benzocaine, Teething, Methemoglobinemia, Public Citizen, OTC Monograph

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