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8/31/1998

ASHP Presents Comments at CDER Stakeholder Meeting

On August 17, Charles E. Myers, ASHP's Assistant Vice President for Professional, Scientific and Public Affairs, participated in one of a series of "stakeholder meetings" the FDA is holding to comply with Section 406(b) of FDAMA. That section of the law requires the agency to consult with scientific and academic experts, health care professionals, patient advocacy and consumer group representatives, and the industries regulated by the agency and develop a plan describing how the FDA intends to meet its statutory obligations under the entire Food, Drug and Cosmetic Act, not just the newly enacted FDAMA. 

The August 17 meeting was the FDA Center for Drug Evaluation and Research's (CDER) opportunity to gather ideas from relevant stakeholders relating to drug approvals, drug marketing and promotion, providing drug information to consumers and health professionals, and adverse event reporting and surveillance. ASHP's comments at the meeting summarized the Society's policies and comments to the agency on various regulatory proposals. 

To view the full report, click here

Posted 8/31/98—Source ASHP's Government Affairs Division