FDA Guidance Documents
FDA Guidance Documents
Stay current with the latest FDA guidance documents affecting drug, biologic, device, and diagnostic development. Browse recently issued and updated guidance to identify evolving regulatory expectations, compliance considerations, and recommendations that may influence your development and testing strategies.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This guidance is one in a series of guidances that provide recommendations...
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated...
This guidance document provides the FDA's recommendations on information to support premarket notification (510(k)) submissions for hemodialysis blood tubing sets....
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.” This guidance provides recommendations to applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids of all potency groups (referred to in this...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Psychedelic Drugs: Considerations for Clinical Investigations.” Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed...
The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antivirals (the Division) regarding the submission of next-generation sequencing (NGS) protocols, data, and analyses in support of resistance assessments for the development of antiviral drugs. The Division performs independent analyses of all NGS...
We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola disease to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). We are also providing you with...
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close...
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close...
