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The FDA’s capacity to evaluate new and genericdrug applications and its oversight over drug manufacturing are why we have this degree of assurance. For new or genericdrugs to work in a patient, they must, of course, be made correctly by using Current Good Manufacturing Practices. drug supply.
Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the GenericDrug Boom.” For an excellent overview of the EU’s regulatory system, see: Excellent overview of the European Union’s drug regulatory system.
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