Documents

Federal rules and notices from the public comment record, analyzed continuously.

FDAOther

Citizen Petition from Alliance for Pharmacy Compounding

4 comments · 1 awaiting analysis

Net support +33% across analyzed comments

Top issues in comments

  • Regulatory classification of dte
  • Safety and efficacy of dte
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FDAOther

Citizen Petition from Siri & Glimstad, LLP (on behalf of Informed Consent Action Network)

4 comments

Net support +100% across analyzed comments

Top issues in comments

  • Vaccine safety and adjuvants
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FDAOther

Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards - Final Guidance

4 comments

Net support +25% across analyzed comments

Top issues in comments

  • Ind safety reporting requirements
  • Investigator lifecycle management
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FDAOther

Citizen Petition from End Kratom Addiction

3 comments

Net support +33% across analyzed comments

Top issues in comments

Not yet determined
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FDAOther

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Guidance for Industry; Draft Guidance

3 comments · 1 awaiting analysis

Net support +100% across analyzed comments

Top issues in comments

Not yet determined
Read the record →Closes Sep 23
FDAOther

Citizen Petition from Valisure LLC

3 comments

Net support +33% across analyzed comments

Top issues in comments

  • Analytical testing methods
  • Benzene impurity risk assessment
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FDANotice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 060

3 comments

Net support 0% across analyzed comments

Top issues in comments

Not yet determined
Read the record →
FDANotice

Request for Comments on the Science and Technology Report; Establishment of Docket; Request for Comments

3 comments

Net support +33% across analyzed comments

Top issues in comments

  • Collaboration with professional societies
  • Nctr organizational role and capabilities
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FDAOther

Citizen Petition from Evan H. Couture

3 comments

Net support +100% across analyzed comments

Top issues in comments

  • Regulatory consistency
  • Regulatory parity and consistency
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FDAOther

General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff

3 comments

Net support -67% across analyzed comments

Top issues in comments

  • Consumer confusion and safety
  • Validation standards for wellness products
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FDAOther

Citizen Petition from Students for Life of America

3 comments · 1 awaiting analysis

Net support -100% across analyzed comments

Top issues in comments

Not yet determined
Read the record →
FDAOther

Citizen Petition from Students for Life of America

3 comments · 1 awaiting analysis

Net support -100% across analyzed comments

Top issues in comments

Not yet determined
Read the record →