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   &lt;pre&gt;[Congressional Record Volume 167, Number 71 (Monday, April 26, 2021)][House]From the Congressional Record Online through the Government Publishing Office [&lt;a href="https://www.gpo.gov"&gt;www.gpo.gov&lt;/a&gt;]By Ms. BARRAGAN:H.R. 2831.Congress has the power to enact this legislation pursuantto the following:Article 1 Section 8 of the United States Constitution[Page H2114]&lt;/pre&gt;
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     Fair Care Act of 2022
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     8588
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      Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
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     Introduced in House
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     2021-09-01T15:53:00Z
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     &lt;p&gt;&lt;strong&gt;Prompt Approval of Safe Generic Drugs Act&lt;/strong&gt;&lt;/p&gt; &lt;p&gt;This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information.&lt;/p&gt; &lt;p&gt;Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall not be considered mislabeled for lacking such safety information. &lt;/p&gt; &lt;p&gt;Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug.&lt;/p&gt; &lt;p&gt;For any drug approved under this bill, the FDA shall require the drug's labeling to include any safety information that is necessary to assure safe use.&lt;/p&gt;
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   Prompt Approval of Safe Generic Drugs Act
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     Prompt Approval of Safe Generic Drugs Act
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     To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes.
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    Referred to the Subcommittee on Health.
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   Congressional Research Service, Library of Congress
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   This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
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2021-04-27
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-04-26
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
2021-04-26T16:00:21Z
Referred to
House
Energy and Commerce Committee
2021-04-27T13:19:18Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
Congressional Research Service, Library of Congress
This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
2021-04-26
2021-04-27
Referred to the Subcommittee on Health.
House
Health
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Fair Care Act of 2022
HR
B001300
44
Nanette
Rep. Barragan, Nanette Diaz [D-CA-44]
N
Barragan
Diaz
D
CA
Drug safety, medical device, and laboratory regulation Marketing and advertising
2021-04-26
Introduced in House
 <p><strong>Prompt Approval of Safe Generic Drugs Act</strong></p> <p>This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information.</p> <p>Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall not be considered mislabeled for lacking such safety information. </p> <p>Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug.</p> <p>For any drug approved under this bill, the FDA shall require the drug's labeling to include any safety information that is necessary to assure safe use.</p>
2021-09-01T15:53:00Z
00
2021-04-26T04:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr2831ih/xml/BILLS-117hr2831ih.xml
Prompt Approval of Safe Generic Drugs Act
Prompt Approval of Safe Generic Drugs Act
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Prompt Approval of Safe Generic Drugs Act
Short Title(s) as Introduced
HR
2023-03-08T20:26:24Z
2023-03-08T20:26:24Z
3.0.0
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Fair Care Act of 2022
HR
2021-04-27
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-04-26
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
B001300
44
Nanette
Rep. Barragan, Nanette Diaz [D-CA-44]
N
Barragan
Diaz
D
CA
Drug safety, medical device, and laboratory regulation Marketing and advertising
2021-04-26
Introduced in House
 <p><strong>Prompt Approval of Safe Generic Drugs Act</strong></p> <p>This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information.</p> <p>Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall not be considered mislabeled for lacking such safety information. </p> <p>Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug.</p> <p>For any drug approved under this bill, the FDA shall require the drug's labeling to include any safety information that is necessary to assure safe use.</p>
2021-09-01T15:53:00Z
00
Prompt Approval of Safe Generic Drugs Act
Prompt Approval of Safe Generic Drugs Act
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Prompt Approval of Safe Generic Drugs Act
Short Title(s) as Introduced
2021-04-27
Referred to the Subcommittee on Health.