In the June 10 Federal Register, FDA amended its postmarketing safety reporting regulations for human and drug biological products to require those subject to mandatory reporting requirements to submit safety reports electronically for FDA to process, review, and archive. The new requirement of electronic submissions will help FDA more quickly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information. The amendments will also be a key part of aligning FDA's postmarketing safety reporting regulations with international standards for electronic submission of such information. In the same Federal Register, FDA also released an accompanying draft guidance for industry, Providing Submissions in Electronic Format—Postmarketing Safety Reports. The rule is effective June 10, 2015; comments on the Draft Guidance are due August 11, 2014.
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