OTC Medicines

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CHPA comments on the Agency’s review and action on OTC time and extent applications. This proposed rule would supplement the time and extent application process for OTC drugs by establishing timelines and performance metrics for the Agency’s review of non-sunscreen TEAs.

May 17, 2016

CHPA is pleased to lend its strong support for the DXM Abuse Prevention Act (S. 2994), introduced into the U.S. Senate by Senators Bob Casey Jr. (D-PA) and Lisa Murkowski (R-AK).

May 16, 2016

CHPA issued the following statement following the Food and Drug Administration’s announcement of a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription monograph drugs.

May 10, 2016

CHPA applauds the state of Georgia for becoming the thirty-third state to adopt the real-time, stop-sale technology called the National Precursor Log Exchange (NPLEx).

Apr 28, 2016

CHPA, which represents leading manufacturers of OTC cough medicines, strongly supports this legislation and is joined many by substance abuse prevention organizations such as the Community Anti-Drug Coalitions of America and the Partnership for Drug-Free Kids.

Apr 20, 2016

These comments are submitted on behalf of CHPA in response to the National Institutes of Health notice entitled, “Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information”.

Apr 18, 2016

CHPA spoke today before a Food and Drug Administration Advisory Nonprescription Drugs Advisory Committee, during which the committee discussed data submitted by Galderma Laboratories, L.P. to support the supplemental new drug application for over-the-counter marketing of adapalene gel 0.1%.

Apr 15, 2016

CHPA released the following statement today in support of a Florida law prohibiting the sale of OTC medicines containing the cough suppressant dextromethorphan (DXM) to minors.

Apr 1, 2016

In general, CHPA supports FDA's intent to harmonize the requirements for Rx and OTC products and make them consistent with long-standing Agency policy.

Mar 22, 2016

Comments regarding guidance for industry pertaining to sunscreen ingredients requesting inclusion into the OTC sunscreen monograph.

Feb 22, 2016

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