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Simplifying the Generic Drug Application Process Act

USA117th CongressS-1462| Senate 
| Updated: 4/29/2021
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (1)
Tina Smith (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Simplifying the Generic Drug Application Process Act This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug. Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.
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Timeline
Apr 29, 2021
Introduced in Senate
Apr 29, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • April 29, 2021
    Introduced in Senate


  • April 29, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Drug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugs

Simplifying the Generic Drug Application Process Act

USA117th CongressS-1462| Senate 
| Updated: 4/29/2021
Simplifying the Generic Drug Application Process Act This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug. Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Apr 29, 2021
Introduced in Senate
Apr 29, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • April 29, 2021
    Introduced in Senate


  • April 29, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill Cassidy

Bill Cassidy

Republican Senator

Louisiana

Cosponsors (1)
Tina Smith (Democratic)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationLicensing and registrationsPrescription drugs