Improving Regulatory Transparency for New Medical Therapies Act

Summary

Improving Regulatory Transparency for New Medical Therapies Act This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs. This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately. For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later. Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 1 October 2015

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• Reported to Senate (PDF)

  Reported to Senate · EN · 1 October 2015

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• Reported to Senate with amendment(s)

  summary · EN · 1 October 2015

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• Introduced in Senate (text)

  Introduced in Senate · EN · 12 February 2015

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 12 February 2015

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• Introduced in Senate

  summary · EN · 12 February 2015

  Open at official source

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