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Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
The building in 1967. The Endo Pharmaceuticals Building, also known as "Endo Laboratories", is a pharmaceutical plant designed by architect Paul Rudolph in 1962 in Garden City, New York, in the receding farmlands of Long Island. The "castle-like structure" was built to house the Endo Pharmaceuticals research, manufacturing and administration ...
The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed Bureau of Biologics and focused on vaccines, serums for allergy shots, and blood products. [8] Ten years later, with the beginning of the biotechnology revolution, the line between a drug and a biologic, or a device and a biologic, became blurred. [8]
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Laboratory-developed tests have long skirted FDA oversight, though the agency has always maintained that it has the authority to step in. Debate over regulating the space stretches back to the ...
For years, the agency had allowed labs to use their in-house tests to diagnose a range of conditions if they met certain standards, without a traditional authorization process. ... US FDA tightens ...
The main entrance of the FDA campus, at 10903 New Hampshire Avenue, retained the setting of the previous use with a large open space (a portion of the golf course, which had closed), a linear drive, and the renovation and integration of the original NOL Administration Building into the new FDA headquarters. [11]