Documents

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

FDANotice

FDA Rare Disease Innovation Hub Future Programming; Request for Comments

17 comments · 1 awaiting analysis

Net support +100% across analyzed comments

Top issues in comments

  • Rare disease regulatory flexibility
  • Digital twins and in silico trials
  • Equity in rare disease care
Read the record →Closes Jan 1
FDAOther

Citizen Petition from Tirza Eden

13 comments

Net support -8% across analyzed comments

Top issues in comments

  • Wild horse protection
  • Chemical spay safety and welfare
  • Transparency and population counts
Read the record →
FDARFI

Butylated Hydroxytoluene (BHT); Request for Information

12 comments

Net support +75% across analyzed comments

Top issues in comments

  • Cumulative dietary exposure
  • Impact on animal food
  • Supply chain impacts
Read the record →Closes Sep 1
FDAOther

Guidance for Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

10 comments

Net support +40% across analyzed comments

Top issues in comments

  • Retesting procedures
  • Api storage conditions
  • Contract laboratory responsibilities
Read the record →
FDAOther

Food Program Guidances Under Development - June 2021

9 comments

Net support 0% across analyzed comments

Top issues in comments

  • Plant-based milk labeling
  • Cross-contamination labeling
  • Food allergy labeling on medications
Read the record →
FDAOther

Citizen Petition from Washington Action for Safe Water

8 comments · 1 awaiting analysis

Net support +100% across analyzed comments

Top issues in comments

  • Fluoride as a drug
Read the record →
FDAOther

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry - Final Guidance

7 comments

Net support 0% across analyzed comments

Top issues in comments

  • Medical cannabis use
  • Cannabis product regulation
  • Dshea botanical classification
Read the record →
FDAOther

Citizen Petition from SafeVetMeds, Inc.

6 comments

Net support +100% across analyzed comments

Top issues in comments

  • Adverse drug reactions
Read the record →
FDAOther

Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations; Guidance for Industry and Food and Drug Administration Staff - Final Guidance

6 comments

Net support 0% across analyzed comments

Top issues in comments

  • Unconsented bci removal
  • Informed consent for neural data
Read the record →
FDAOther

The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels: Guidance for Industry

5 comments

Net support +40% across analyzed comments

Top issues in comments

  • Allulose labeling requirements
  • Labeling requirements
  • Bcaa caloric labeling
Read the record →
FDAOther

Citizen Petition from Covington & Burling LLP on Behalf of Novo Nordisk Inc.

5 comments · 2 awaiting analysis

Net support -33% across analyzed comments

Top issues in comments

  • Compounded glp-1 access
  • Compounding pharmacy access
Read the record →
FDAOther

Development of 21st Century Cures Act Section 3060 Required Report: Request for Input

4 comments · 1 awaiting analysis

Net support +100% across analyzed comments

Top issues in comments

Not yet determined
Read the record →Closes Aug 14