Documents

FDAOther

Clinical Decision Support Software Guidance for Industry and Food and Drug Administration Staff

FDAOther

Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Guidance for Industry; #284

FDAOther

Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry DRAFT GUIDANCE

FDAOther

Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry

FDAOther

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry

FDAOther

Citizen Petition from Nicholas Warack, et al.

FDAOther

Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application; Guidance for Industry

FDAOther

Citizen Petition from Earthjustice, et. al.

FDAOther

Citizen Petition from Connor Carmichael

FDANotice

Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

FDAOther

Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug; Guidance for Industry

FDANotice

Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments