FDA's Readiness Questioned In Electronic AER Comments
This article was originally published in The Tan Sheet
FDA's planned move to mandatory electronic filing of adverse event reports is raising concerns about costs for small businesses and the agency's ability to fully integrate its growing number of electronic filing requirements
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The Consumer Healthcare Products Association says FDA's proposed rule concerning mandatory requirements for electronic submission for postmarketing safety reports on drugs and biological products should extend to nonprescription and OTC monograph drugs in addition to OTCs marketed with approved applications, the group said Nov. 10 (1"The Tan Sheet" Aug. 24, 2009). FDA's Aug. 21 posting in the Federal Register proposes OTCs marketed with approved applications, whether with a new drug application and abbreviated new drug application, comply with the rule, and asked for comments on whether OTCs not marketed with approval applications should be subject to the same electronic submission requirements for adverse event reports
A report of emergency room treatment connected to use of a dietary supplement may not connote a serious adverse event, FDA says in the final guidance on the reporting and recordkeeping of AE information for supplements
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