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 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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close...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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close...
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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close...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 caprine 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 ovine 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 bovine 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:...
The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in veterinary species. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating anthelmintic drugs...
The present guidance for chickens 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...
