Nonrulemaking

Providing Comments on CDER Level 2 Guidances

🏛 Food and Drug Administration (FDA)FDA-2017-D-6821

Biomedical Research Pharmaceutical Policy

Documents

6

Total comments

1

all analyzed

Comment status

Open

Last activity

Jun 23, 2026

In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

📄 Primary document

OtherJul 1, 2026

Submitting Next-Generation Sequencing Data to the Division of Antivirals; Guidance for Industry

No comment period

Other· Jun 18, 2026
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug; Guidance for Industry→
No comment period💬 1
Other· May 7, 2026
Submitting Continuous Glucose Monitoring Data in Clinical Trials Guidance for Industry→
No comment period