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Press Releases and Statements

CHPA Statement on the House Passage of the 21st Century Cures Initiative

CHPA applauds the Energy and Commerce Committee on House passage of the 21st Century Cures initiative. CHPA looks forward to the implementation of these provisions and believes it will help accelerate the discovery, development, and delivery of new treatments and cures for patients

Jul 10, 2015

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Press Releases and Statements

Makers of Over-the-Counter Medicines Support Washington State Sales Law on Cough Medicine Taking Effect Today

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

Jul 1, 2015

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Submission

Comments to FDA: Formal Meetings Between FDA and Sponsors of PDUFA Products

CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.

Jun 3, 2015

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Submission

Comments to FDA: Toxicological Principles for the Safety Assessment of Food Ingredients

FDA intends to expand the scope of Redbook to include chemical safety assessments for all products over which FDA's Center for Food Safety and Applied Nutrition has statutory authority. We urge FDA to provide clear and specific guidance for applying these principles within each particular context.

May 8, 2015

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Submission

Letter to FDA: ILR Request to Participate

Please accept this letter as an official request from the CHPA to participate in the selection process for nonvoting industry representatives for several public advisory committees for the Center for Drug Research & Evaluation.

Apr 15, 2015

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Press Releases and Statements

CHPA Thanks Governor Bill Haslam for Signing Legislation

Apr 9, 2015

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Submission

Comments to USP: Proposals for Developing Compendial Quality Standards for OTC Drugs

Letter to Principal Scientific Liaison, U.S. Pharmacopeia, regarding Proposals for Developing Compendial Quality Standards for OTC Drugs.

Apr 3, 2015

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Submission

Side-by-Side Comparison: 21 CFR, Parts 110, 111, 211 and 820

Mar 4, 2015

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Research Reports

A Summary of the Key Differences Between the FDA’s Drug and Dietary Supplement GMPs

In general, the Part 111 GMP requirements, although similar, are less stringent and tend to be more flexible than the Part 211 GMP requirements.

Mar 4, 2015

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Submission

Comments to FDA: Sunscreen Feedback Letters

We ask that in its review of the Proposed Orders, FDA take our framework into consideration when making its GRASE determinations.

Feb 23, 2015

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