Guidance, Compliance, & Regulatory Information
Popular Items
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Affordable Care Act (ACA 6004) -
Compounding -
Drug Compliance Programs -
Guidances (Drugs) -
Newly Added Guidance Documents -
Product-Specific Recommendations for Generic Drug Development -
Nicotine-Containing Products -
Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials -
Office of Compliance - The Office of Prescription Drug Promotion (OPDP)
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PLR Requirements for Prescribing Information -
Regulatory Guidance Drug Registration and Listing -
Sunscreen Innovation Act (SIA) -
Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval -
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies