FDA Issues New cGMP Combination Products Rule

08/03/2013 16:11

The FDA has issued a final rule 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.

Back

Search site

Contact

ECURAC - EU / China / US Regulatory Affairs Consultants European Union
+49 89 21550998
China
+86 131 6119 7082
United States
+1 805 570 6135