PDF versions 1.4 through 1.7, PDF/A-1 and PDF/A-2 are acceptable for documents. Submitted PDF files should be readable by Adobe Acrobat X, should not require additional software or plug-

FDA’s Role • Oldest comprehensive consumer protection government agency • Promote and protect health • Covers foods, drugs, biologics, cosmetics, animal and

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2025年3月4日 · While the official online application, Drugs@FDA, is updated daily, this data file is updated once per week, on Tuesday. Once you have downloaded the compressed file (drugsatfda.zip), you can ...

The table below provides a convenient way to search for FDA guidance documents from a single location. You can search for documents using key words, and you can narrow or filter your results by ...

Guidance for Industry. 1. Process Validation: General Principles and Practices . This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.

ACTEMRA (tocilizumab) injection - Food and Drug Administration

determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 (1.16, 2.1) Limitations of Use: The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC)

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Check that the LEQEMBI solution is clear to opalescent and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.

definition of a medical device, may seek FDA advice. • Contact CDRH Office of Compliance by email at: [email protected] • Provide product description, draft labeling, and ...