Archived documents
Documents past their public comment period for FDA.
FDA ▾
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance
76 comments · 28 awaiting analysis
Net support +63% across analyzed comments
Top issues in comments
- Nonclinical safety assessment streamlining
- Animal testing
- Animal testing alternatives
Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
69 comments
Net support +80% across analyzed comments
Top issues in comments
- Benefits of pfdd meetings
- Lifecycle of patient engagement
- Patient-centered research and advocacy
Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
69 comments · 13 awaiting analysis
Net support +45% across analyzed comments
Top issues in comments
- Oral fluid and hair testing
- Exemption framework scope and flexibility
- Oral fluid testing certification
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.
69 comments · 11 awaiting analysis
Net support -14% across analyzed comments
Top issues in comments
- Patient health and quality of life
- Vaccine safety and efficacy
- Vaccine updates and accessibility
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance
55 comments
Net support +60% across analyzed comments
Top issues in comments
- Classification of protocol deviations
- Reporting responsibilities for deviations
- Guidance specificity and rigor
Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments
52 comments · 2 awaiting analysis
Net support +94% across analyzed comments
Top issues in comments
- Supac guidance clarity
- Guidance consolidation
- Additional change types
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry
42 comments
Net support +76% across analyzed comments
Top issues in comments
- Response format and content
- Scope of guidance application
- Attorney-client privilege and disclosure
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
33 comments
Net support +85% across analyzed comments
Top issues in comments
- Variant-aware off-target analysis
- Optical genome mapping (ogm)
- Rare disease flexibility
Master Protocols for Drug and Biological Product Development; Guidance for Industry; Draft Guidance
26 comments
Net support +81% across analyzed comments
Top issues in comments
- Master protocols guidance
- Master protocol design
- Agency corruption and funding
Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry
19 comments
Net support +63% across analyzed comments
Top issues in comments
- Impurity limits and control strategy
- Terminology and definitions
- Analytical method validation
M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance
19 comments
Net support +63% across analyzed comments
Top issues in comments
- Content clarity and detail
- Document organization and logic
- Analytical procedure documentation
Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
16 comments · 13 awaiting analysis
Net support +100% across analyzed comments
Top issues in comments
- Bmi limitations and alternatives