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.
This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter “Bacterial Endotoxins Test”, USP Chapter “Medical Devices ‒ Bacterial Endotoxin and Pyrogen Tests”, and the Association for the Advancement...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations...
Office of Regulatory Policy The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for...
This guidance document provides the FDA’s recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions (e.g., Premarket Approval (PMA) Applications, Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo classification requests). The guidance also...
This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar...
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar products,...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” This guidance is intended for foreign and domestic human and animal drug manufacturing establishments inspected by...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines.” The guidance was prepared under the auspices of the International Council...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical...
