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CBER is providing interested persons with information concerning the storage and use of temperature-sensitive biological products that have been involved in a temporary electrical power failure or flood conditions. While people should not be put at risk by using a product that may be unsafe due to the conditions under which it was stored, shortages should not be created by discarding product simply because of power failures that may not adversely affect the product. Vials of biological products in contact with flood waters should be discarded given the possibility of contamination and the likelihood of significant exposure to temperatures outside of those recommended for cold chain storage.
The boundaries between these disciplines and with other sciences, such as biochemistry, are not always clear-cut; and often, collaborative teams from various disciplines research together.
In the U.S., the government’s Food and Drug Administration (FDA) must approve any drug – whether it’s prescription or over-the-counter – before it can be sold. The FDA evaluates the safety of a drug by looking at side effects, how it’s manufactured, results of animal testing and clinical trials, and more. The FDA also monitors a drug’s safety after approval.
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