Archived documents
Documents past their public comment period for Healthcare & Public Health.
M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance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
Self-Attestation for Recertification of CORFs, OPT/SLP, and RHCs Providers and PXR Suppliers (CMS-10952A-D)
17 comments
Net support -88% across analyzed comments
Top issues in comments
- Patient safety and oversight
- Rhc survey and certification procedures
- Reduced on-site survey frequency
Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry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
National Healthcare Safety Network (NHSN)
15 comments
Net support -7% across analyzed comments
Top issues in comments
- Nhsn reporting definition accuracy
- Burden of reporting
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Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry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
Expanding Access to State Prescription Drug Monitoring Programs (AS73)
11 comments
Net support +36% across analyzed comments
Top issues in comments
- Immigration enforcement fee amount
Control of Communicable Diseases; Foreign Quarantine
8 comments
Net support -50% across analyzed comments
Top issues in comments
- Travel restrictions effectiveness
- Equitable public health policies
- Public health evidence
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Guidance for Industry; Draft Guidance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
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Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance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
Extended Evaluation of the National Tobacco Prevention and Control Public Education Campaign 2026-07761
6 comments
Net support +100% across analyzed comments
Top issues in comments
- Support for campaign evaluation
Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists
5 comments
Net support -100% across analyzed comments
Top issues in comments
- Agency jurisdiction and expertise
- Lpr travel status
CY 2027 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates. CMS-1850-P Display
5 comments
Net support -60% across analyzed comments
Top issues in comments
- Asc reimbursement rates
- Device-intensive designation
- Missing records as mismatches