PL EN

FDA: Warnings and Precautions, Contraindications, and Boxed Warning Section of Labeling for Human Prescription Drug and Biological

13.10.2011
This guidance is intended to assist applicants and reviewers in drafting the “Warnings and Precautions, Contraindications, and Boxed Warning” sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

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