FDA Current 21 CFR Part 4 Good Manufacturing Practice Requirements for Combination Products
Title:
FDA Current 21 CFR Part 4 Good Manufacturing Practice
Requirements for Combination Products
Origin/Publisher:
US Federal Register
Document Type:
Final Regulation
Content:
The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP)requirements applicable to combination products. This rule is intended to promote the public health by clarifying
which CGMP requirements apply when drugs, devices, and biological products are combined to create combination
products.