Archived documents

FDAOther

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability

FDAOther

Citizen Petition from Fresenius Kabi USA, LLC

FDAOther

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry DRAFT GUIDANCE

FDAOther

Topical Dermatologic Corticosteroids In Vivo Bioequivalence - DRAFT Guidance

FDANotice

Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)

FDAOther

Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Draft Guidance

FDAOther

Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance

FDAOther

Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance

FDAOther

Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance

FDANotice

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

FDANotice

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

FDANotice

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY