FDA Milestones

By Quality Digest, February 2019

Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

1988: Food and Drug Administration Act
Officially establishes the FDA as an agency of the Department of Health and Human Services and broadly spells out the responsibilities for research, enforcement, education, and information.

1988: The Prescription Drug Marketing Act
Requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade, or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.

1990: Safe Medical Devices Act (SMDA)
Provides the FDA with two additional postmarketing activities: postmarket surveillance for the monitoring of products after their clearance to market; and device tracking for maintaining traceability of certain devices to the user level.

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