Archived documents
Documents past their public comment period for FDA.
FDA ▾
Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
53 comments
Net support +45% across analyzed comments
Top issues in comments
- Oral fluid and hair testing
- Exemption framework scope and flexibility
- Oral fluid testing certification
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Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry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Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry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Master Protocols for Drug and Biological Product Development; Guidance for Industry; Draft Guidance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
M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance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
Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry
17 comments
Net support +65% across analyzed comments
Top issues in comments
- Impurity limits and control strategy
- Terminology and definitions
- Analytical method validation
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
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
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
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
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