Archived documents

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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry DRAFT GUIDANCE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Topical Dermatologic Corticosteroids In Vivo Bioequivalence - DRAFT Guidance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Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Draft Guidance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Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance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Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance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Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance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; ZIIHERA

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment, Maintenance, and Availability of Records; Additional Traceability Records for Certain Foods

FDANotice

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Required Warnings for Cigarette Packages and Advertisements

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles and Medicated Feeds

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions