Over-The-Counter Drug Monograph System-Past, Present, and Future; Public Hearing

Legal Alerts

Over-The-Counter Drug Monograph System-Past, Present, and Future; Public Hearing

Published: Monday, February 24, 2014

Editor's Note: FDA announced it will hold a public hearing on March 25 and 26 to gain input on how to improve the OTC drug review or OTC Monograph Process for nonprescription drugs. FDA says it wants to make the process more efficient, more responsive to newly emerging information and evolving science, and allow more rapid product innovation. FDA shares several ideas to spark discussion, including streamlining the process to promptly resolve existing tentative final monographs; using administrative orders to finalize monographs instead of the current notice and comment rulemaking process; and expanding the new drug application deviation process to allow applications to show that the product is in compliance with a monograph except for the deviation and to demonstrate safety and effectiveness.

Food and Drug Administration

Over-The-Counter Drug Monograph System-Past, Present, and Future; Public Hearing

ACTION

Notice Of Public Hearing; Request For Comments.

SUMMARY

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on the Over-The-Counter (OTC) Drug Review (sometimes referred to as the OTC Monograph Process, OTC Monograph, or OTC Drug Review). The Agency would like input on how to improve or alter the current OTC Monograph Process for reviewing nonprescription drugs (sometimes referred to as OTC drugs) marketed under the OTC Drug Review. This public hearing is being 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.

DATES

The public hearing will be held on March 25 and 26, 2014, from 9 a.m. to 4 p.m. The meeting may be extended or may end early depending on the level of public participation. Register to attend or provide oral testimony at the meeting by March 12, 2014. See Registration and Request To Provide Oral Testimony for information on how to register or make an oral presentation at the meeting. Written or electronic comments will be accepted until May 12, 2014.

SUPPLEMENTARY INFORMATION

FDA is announcing a public hearing to obtain input on the OTC Drug Review. We believe that the OTC Drug Review needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework. The Agency is interested in exploring ways to re-engineer the process of regulating OTC drugs that are currently regulated under the OTC Monograph Process to, among other things, create a process that is more efficient and more responsive to newly emerging information and evolving science, and to allow for more rapid product innovation where appropriate. ... 

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