Guidelines on adherence to postmarketing safety reporting requirements for combination products were provided to manufacturers in a proposal by the FDA. The proposal would clarify the postmarketing safety reporting requirements that apply when drugs, devices, and biological products are combined to create a combination product under a streamlined regulatory framework. The proposal would consolidate the repetitive requirements for each constituent part, including reporting death and serious adverse events, and allow reporting requirements associated with the type of marketing application under which the product was approved or cleared.
SOURCE: FDA Proposal
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