
FDA Strengthens Postmarketing Safety Reporting Requirements for Combination Products
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
On March 20, 2018, FDA published two guidance documents that detail postmarketing safety reporting requirements (PMSR) for combination products. The documents address how companies can comply with the 2016 final rule on PMSR for combination products.
Draft guidance,
"We’re taking steps to strengthen and modernize our postmarket safety reporting requirements for combination products. Today we are issuing guidance to manufacturers on how they can provide more complete and relevant information related to combination products. We want to make sure that the process for submitting safety information to the FDA is clear, efficient and promotes timely evaluation of potential safety issues,” said FDA Commissioner Scott Gottlieb, MD, in a press release.
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