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Drugs

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Postmarket Drug Safety Information for Patients and Providers: Selected Safety Regulations

– Labeling
- 201.56 – Requirements on content and format of labeling for human prescription drug and biological product
- Other labeling regulations
- 208 – Medication Guides for Prescription Drug Products
- 310.501 – Patient package inserts for oral contraceptives
- 310.515 – Patient package inserts for estrogens
312 – Investigational New Drug (IND) Application
314 – Applications for FDA Approval to market a New Drug (NDAs)
601 – Biological Licenses

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