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FDA Web Site Provides Treasure Trove of Information

By ALM Staff | Law Journal Newsletters |
November 21, 2003

If you are seeking information about adequate warning labels, go to the Food and Drug Administration's (FDA) Web site (www.fda.gov) and type in “adequate warning labels.” Information will appear in milliseconds, covering everything from correspondence with manufacturers to FDA Public Health Advisories and sections from the Federal Register.

Among the myriad of information are letters to manufacturers explaining why the agency approved or disapproved the manufacturer's labeling for certain uses. For example, a November 2001 letter to Bristol-Myers Squibb concluded that the package inserts presented adequate information regarding the safe and effective use of products containing VIDEX.

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