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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Draft guidance, Postmarketing Safety Reporting for Combination Products, clarifies how companies can meet PMSR requirements under the final rule. The guidance discusses how companies can ensure consistent, timely, and complete reporting of adverse events. Under certain circumstances, manufacturers may submit a single report to satisfy multiple reporting requirements and submission timelines. When and how co-applicants of combination products must share safety information about a combination product with one another under the PMSR final rule are also discussed in the guidance.
Compliance Policy for Combination Product Postmarketing Safety Reporting outlines FDA’s compliance policy for the PMSR final rule. The agency put the guidance into effect to quickly communicate the new compliance policy because of upcoming compliance deadlines for certain provisions of the PMSR final rule so that companies can prepare. FDA, however, will review all comments received and revise the guidance as appropriate. Certain requirements under the PMSR final rule will not be enforced for a period of time to ensure that combination product applicants have sufficient time to update reporting and recordkeeping systems and procedures and consider the recommendations and technical specifications in the final version of Postmarketing Safety Reporting for Combination Products.
"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.