FDA will issue a long-awaited final rule Jan. 22 on current good manufacturing practice (CGMP) requirements for combination products. The rule clarifies which manufacturing quality requirements apply when drugs, devices and biological products are combined to create combination products. The rule finalizes a September 2009 proposed rule, which itself took four years to develop. (See Also see "Proposed Rule Defines Good Manufacturing Practices For Combo Products" - Medtech Insight, 28 September, 2009..) The regulation also lays out a streamlined approach for firms that make single-entity or co-packaged combo products at the same facility. These firms can adopt one operating system as the baseline, and then add additional procedures as needed. FDA notes that the final rule is “largely identical” to the proposed rule. The agency made minor adjustments based on the 25 comments it received on the proposal.
FDA will also issue a draft guidance document Jan. 22 on submissions for post-approval modifications to a combination...
