FDA Proposes Mandatory Electronic Submission of AERs For Some Drugs
This article was originally published in The Tan Sheet
Executive Summary
FDA will require manufacturers to submit electronically adverse event reports for most drugs, biologics and devices, in order to identify post-marketing safety risks more quickly, cut costs and harmonize international reporting standards
You may also be interested in...
CHPA comments on OTCs in AER submission rule
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
CHPA comments on OTCs in AER submission rule
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
CHPA comments on OTCs in AER submission rule
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