Increasing Transparency in Generic Drug Applications Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
This bill, the Increasing Transparency in Generic Drug Applications Act, aims to increase transparency in the process of reviewing generic drug applications. Specifically, it requires the Food and Drug Administration (FDA) to inform a drug applicant whether a generic drug is qualitatively and quantitatively the same as the brand-name drug it’s intended to match. If a difference is found, the FDA must disclose the specific ingredients causing the difference and the amount of any deviation. The bill also mandates the FDA to issue guidance on how it will determine this comparability, allowing for public comment before finalizing the guidance.
Key provisions
- Requires the FDA to inform applicants if a generic drug is qualitatively and quantitatively the same as the brand-name drug.
- If a difference is found, the FDA must disclose the specific ingredients causing the difference and the amount of any deviation.
- Establishes a process for the FDA to issue guidance on determining drug comparability.
- Requires the FDA to solicit public comment on draft guidance.
- Final guidance must be published within one year of the comment period.
- The new requirements apply from the date of enactment of the bill.
- Clarifies that disclosures are authorized by law, including for purposes of section 1905 of title 18, United States Code.
- Protects confidential information related to listed drugs.
Who is affected
- Pharmaceutical companies
Bill text
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7 on record
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