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.
The present guidance for felines was developed by the Working Group established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Anthelmintic Guidances, and subsequently revised in 2024. It should be read in conjunction with Guidance for Industry (GFI) #90 (VICH GL7), “Effectiveness...
The present guidance for canines was developed by the Working Group established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Anthelmintic Guidances, and subsequently revised in 2024. It should be read in conjunction with Guidance for Industry (GFI) #90 (VICH GL7), “Effectiveness...
The present guidance for porcines was developed by the Working Group established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Anthelmintic Guidances, and subsequently revised in 2024. It should be read in conjunction with Guidance for Industry (GFI) #90 (VICH GL7), “Effectiveness...
This equine guidance was developed by the Working Group established by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Anthelmintic Guidances, and subsequently revised in 2024. It should be read in conjunction with Guidance for Industry (GFI) #90 (VICH GL7), “Effectiveness of Anthelmintics:...
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...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled “Forms FDA 3542a and FDA 3542: Questions and Answers.” This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542 and to assist applicants in...
This guidance describes the Food and Drug Administration’s (FDA’s) intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, FDA believes the devices being added to this guidance meet the standards for exemption from premarket notification requirements. Until such exemption occurs, or until FDA becomes aware...
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...
