Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

**JANUARY 2019 GUIDANCES:

IMMUNOGENICITY TESTING OF THERAPEUTIC…

We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  When the FR is available, this document will be available in the FR as will a notice detailing how to submit comments on this document. There is an existing Docket Number, FDA-2009-D-0539, for this document, which is accessible on www.Regulations.gov

Labeling for Human Prescription Drugs…

We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  When the FR is available, this document will be available in the FR as will a notice detailing how to submit comments on this document. There is an existing Docket Number, FDA-2018-D-4603, for this document which is accessible on www.Regulations.gov




Newly Added Guidance Documents

Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.






https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

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