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Posts Tagged ‘transparency initiative’

Upcoming Event: Webinar on FDA’s MedWatch System: How to Report Adverse Events

October 18, 2011 18 comments

Did you know that you can report problems that you have had with drugs and other medical products to the FDA? Did you know that MedWatch can send safety alerts directly to you, as soon as they appear on the web site?

The FDA will host a webinar “FDA’s MedWatch System: How to Report Adverse Events”. The featured speaker, Brenda Rose Pharm.D., a Health Programs Coordinator in FDA’s Office of Special Health Issues will give an overview and answer questions about how to report adverse events to MedWatch.

The free 30 minute webinar will be held Thursday, October 20th at 11 AM ET.

There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.

Learn more about the webinar, including instructions about how to join.

New sources of FDA enforcement information posted

May 26, 2011 28 comments

Today, the FDA is implementing the first in a series of proposals to increase public understanding of the public health impact of FDA’s enforcement efforts, help inform companies’ efforts to comply with FDA requirements, increase company accountability to consumers and business partners, and help consumers make more informed decisions about the products they buy.

This action stems directly from the FDA Transparency Initiative, which Commissioner Margaret A. Hamburg, M.D. launched in 2009. The initiative is designed to examine all agency activities and consider ways to make them more transparent. After holding public meetings and inviting written comments, FDA issued its first report, proposing 21 actions to increase disclosures about agency activities.  Today, the agency is taking several steps to increase transparency related to its enforcement activities:

• Posting a summary of the most common inspectional observations of objectionable conditions or practices that are made during inspections.

• Providing a searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification.

• Alerting the public in a consistent manner about enforcement actions, by issuing press at the beginning and the end of the process, unless confidentiality is necessary.

The FDA is also providing a new web page to house all of the agency’s key transparency activities related to enforcement so that these resources will be easier to find and use.

In the coming months, 3 additional enforcement-related transparency actions will be implemented. FDA will begin to disclose additional information about FDA evaluations of importers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall. FDA will also move forward on other proposals in the report.

Ann Witt
Transparency Coordinator

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