FDA Extends Period for Public Comment on Modernizing OTC Monograph Process

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-09-2014 11:22

The US Food and Drug Administration (FDA) is reopening the comment period for the notice of public hearing, published in the Federal Register of February 24, 2014, requesting comment on how to improve or alter the current Over-the-Counter (OTC) Monograph Process for reviewing nonprescription drugs marketed under the OTC Drug Review. FDA is reopening the comment period to update comments and to receive new information. The original comment period ended May 12, 2014, and the FDA has now extended it to July 31, 2014.

FDA has been assessing the OTC Monograph Process and, in particular, has been considering how effectively the monograph system is functioning, 40 years after its inception, from scientific, policy, and process perspectives. In the February notice of public hearing, FDA announced it was soliciting comments about whether and how to modernize the process for the future. A public hearing was held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, and to obtain and discuss ideas about modifications or alternatives to this process. Interested persons were originally given until May 12, 2014, to comment on the OTC Monograph Process.

To date, the agency has received 15 public comments, including input from the Consumer Healthcare Products Association, the International Pharmaceutical Excipients Council of the Americas, and the US Pharmacopeial Convention as well as from Johnson & Johnson, GlaxoSmithKline Consumer Healthcare, and Procter & Gamble.

See related story, "Novartis, GSK, Bayer and Merck Become Movers in the OTC Market"

Source: Federal Register

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