Improving Regulatory Transparency for New Medical Therapies Act

Summary

Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to direct the Attorney General, within 45 days of receiving a recommendation from the Secretary of Health and Human Services (HHS) to add a drug or substance that has never been marketed in the United States to a schedule of controlled substances, to issue an interim final rule, under the exception for good cause, placing the drug or substance into the schedule recommended by the Secretary. Makes the interim final rule immediately effective. Authorizes a person who submits an application for registration to manufacture or distribute a controlled substance to indicate on the application that the substance will be used only in connection with clinical trials of a drug in accordance with the Federal Food, Drug, and Cosmetic Act. Directs the Attorney General to make a final decision on an application that includes such an indication within 180 days or provide written notice to the applicant of the outstanding issues that must be resolved to reach a final decision and the estimated date such decision will be made.

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Documents

7 official files

• Reported in House (text)

  Reported in House · EN · 19 September 2014

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• Reported in House (PDF)

  Reported in House · EN · 19 September 2014

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• Reported to House amended, Part II

  summary · EN · 19 September 2014

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• Reported to House without amendment, Part I

  summary · EN · 29 July 2014

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• Introduced in House (text)

  Introduced in House · EN · 26 March 2014

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• Introduced in House (PDF)

  Introduced in House · EN · 26 March 2014

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• Introduced in House

  summary · EN · 26 March 2014

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