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 is intended to assist holders of abbreviated new drug applications (ANDAs) approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) by highlighting certain statutory and regulatory requirements for ANDAs postapproval, as well as identifying related guidances and other resources that...
We, the FDA, are issuing this draft guidance to assist you (manufacturers, applicants, and other stakeholders) in developing human gene therapy (GT) products incorporating ex-vivo and in vivo genome editing (GE) of human somatic cells (GE products). Specifically, this guidance reflects FDA’s current thinking on the type of prior knowledge...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “M15 General Principles for Model-Informed Drug Development.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance...
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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close...
This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the...
Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to clarify key issues. The guidance reflects the current working procedure of the ICH Quality Implementation Working...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments,...
In line with the FDA Roadmap to reduce animal testing in product development and based on the FDA Review Division’s experience and data analysis, the Agency is communicating approaches to evaluate the safety of certain oncology pharmaceuticals, which provide safety information that is equivalent or superior to animal studies. These...
The FDA recognizes and anticipates that the Agency and industry may need a minimum of 60 days to perform activities to operationalize the policies within this guidance. For regulatory submissions that are currently pending with the FDA after publication of the guidance, as well as those submissions received before August...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Statistical Approaches to Establishing Bioequivalence.” This guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug...
