Archived documents

Documents past their public comment period for FDA.

FDAOther

Food Additive Petition seeking amended food additive regulations to remove FDA's approval of four carcinogenic solvents

14 comments

Net support -14% across analyzed comments

Top issues in comments

  • Removal of carcinogenic food additives
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FDAOther

FDA Review of Select Ortho-Phthalate Food Contact Substances as Chemically or Pharmacologically Related (CPR) Substances

13 comments · 9 awaiting analysis

Net support +100% across analyzed comments

Top issues in comments

Not yet determined
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FDAOther

Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry

13 comments · 8 awaiting analysis

Net support +40% across analyzed comments

Top issues in comments

Not yet determined
Read the record →Closes Dec 22
FDANotice

Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments

12 comments · 11 awaiting analysis

Net support 0% across analyzed comments

Top issues in comments

Not yet determined
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FDANotice

Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments

9 comments · 4 awaiting analysis

Net support +80% across analyzed comments

Top issues in comments

  • Independent batch testing
  • Nitrosation reaction rate
  • Pediatric drug development
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FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey

8 comments · 8 awaiting analysis

Analysis in progress

Top issues in comments

Not yet determined
Read the record →
FDARFI

Azodicarbonamide (ADA); Request for Information

7 comments · 5 awaiting analysis

Net support +100% across analyzed comments

Top issues in comments

Not yet determined
Read the record →
FDAOther

Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Guidance for Industry; Draft Guidance

7 comments · 7 awaiting analysis

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Jul 20
FDAOther

Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff

7 comments

Net support +100% across analyzed comments

Top issues in comments

  • Regulatory oversight and clarity
  • Clarify intended audience
  • Occupational safety and heat stress
Read the record →Closes Jun 23
FDAOther

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance

6 comments · 5 awaiting analysis

Net support 0% across analyzed comments

Top issues in comments

Not yet determined
Read the record →Closes Jul 25
FDANotice

Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments

6 comments

Net support +67% across analyzed comments

Top issues in comments

  • Gs1 standards adoption
  • Imprinting requirements on individual packages
  • Mobile application for traceability
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FDARFI

Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information

4 comments · 3 awaiting analysis

Net support +100% across analyzed comments

Top issues in comments

  • Pediatric and neonatal considerations
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