FDA Guidance Documents
Technotes
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.
Prior to approving an antimicrobial new animal drug application, FDA must determine that the drug is safe and effective for its intended use in the animal, including an evaluation of the potential microbiological effects of the drug residues on bacteria of human health concern....
This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency's recommendations and expectations regarding the development of delivery devices and container closure systems described in Q.I.4 of the...
FDA has developed this guidance document to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments....
This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS)....
This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS)....
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: Laboratory Values." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria...
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...
