The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically. The guidance follows a final rule and corresponding draft guidance issued by the agency in 2014 to streamline the safety reporting process.
On 27 April FDA published the Providing Submissions in Electronic Format—Postmarketing Safety Reports final guidance. The draft version was published in 2014 and applies to a wide swath of products including those with new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLA), as well as certain combination products and compounded drugs.
The guidance notably does not apply to vaccines, certain blood products, combination products marketed under a device application, and certain cell and tissue products…
