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FDA Web Site Provides Treasure Trove of Information
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.
There is a link to a document explaining the FDA's medical gas requirements, called Fresh Air '2000.' The program provides the FDA's interpretation of how the minimum current good manufacturing practice regulations apply to the manufacturing, filling, transfilling, cascading, etc. of medical gases, both compressed and cryogenic. (Medical gases are prescription drugs that must be dispensed by prescription only. Each firm has a responsibility to determine if its consignee, not the patient, is authorized to purchase the drug gas, and if required, is registered with the FDA and properly licensed with the state, where required, prior to selling them medical gas.)
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