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Overall Survival in Oncology Clinical Trials

Submit Comments by 10/20/2025 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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...

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Information for Health Care Professionals

FAQ: Labeling Requirements Review information about patient labeling, including medication guides, patient package inserts, and instructions for use. FDALabel The FDALabel database offers detailed drug labels for FDA-approved medications, including reported side...

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