Manufacturers Seek More Clarity On GMP Obligations For Combo Products
This article was originally published in The Gray Sheet
Manufacturers support the gist of FDA’s draft guidance on combination product current good manufacturing practices, but they want more clarity on roles, quality requirements, design controls and stability testing, according to written comments.
You may also be interested in...
FDA has delivered a draft current good manufacturing practices guidance for combination products, providing details and examples on how the agency regulates drug delivery devices and other drug/device, drug/biological and drug/device/biological products.
Operation Warp Speed will hold back initial shipments to ensure two-dose regimens can be completed; 15 December is ‘chalk’ target date for emergency authorization of Pfizer vaccine, OWS’ Gustave Perna says, calling it only a projection that does not impinge on FDA authority. Sending only half shipments also eases burden on cold shortage capacity at state and local level, he says.
CMS acknowledges stakeholders may need more details about the plan before it is finalized and a delay will give the agency more time to ‘consider the issue.’