Dr. Hamburg was joined by Paul Glover of Health Canada and Guido Rasi of the European Medicines Agency at the Drug Information Association’s 48th annual meeting.
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The FDA was recently scrutinized by Congressional members who believe the agency has impeded job creation by shutting down plants with quality control problems. Dr. Hamburg stressed quality concerns, such as glass shards and metal fractures in tobacco products, could not be ignored by the FDA and other regulators.
Mr. Glover added a universal reporting mechanism could more quickly alert regulators about adverse events and promote patient safety around the world.
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