2024年12月17日 · FDA Centers and Offices publish annual Guidance Agendas, which list possible topics for future guidance document development or revision during the upcoming year.

This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological

2024年10月1日 · This guidance is a summary of the required statements for food labels under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Guidance for …

2025年1月22日 · The Draft Guidance provides clarity to the industry on how the requirements of § 211.110 can be met and is a reflection of FDA’s continued focus on advanced manufacturing. …

2023年12月22日 · The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological …

2024年11月20日 · FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients:

2025年1月7日 · The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for the Use of Artificial Intelligence To …

2025年1月7日 · Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

This guidance provides recommendations for the development of drugs and therapeutic biologics regulated within the Center for Drug Evaluation and Research at the Food and Drug …

This guidance specifically addresses the importation of FDA-approved drugs that are also authorized for sale in a foreign country in which the drugs were originally intended to be …