The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register. The FDA issued a proposed rule to clarify the cGMP requirements applicable ...

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.

Navigating FDA's rules to get a fixed-dose combination therapy for chronic obstructive pulmonary disease approved required a large study and a specific population. When GlaxoSmithKline designed the ...