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The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate comm...
Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PM...
In US, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across sta...
The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate...
Recalled! retrieves all Recalls, Recall Alerts and Press Releases from the US Consumer Product Safety Commission (CPSC) and Recalls and Safety Alerts ...
Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). The manufacture of steri...
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