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“Perhaps no investigation better illustrates our prosecutors’ resolve than our ongoing investigation into the generic pharmaceutical industry,” said DOJ Deputy Assistant Attorney General Richard Powers. Read More
A manufacturer that uses an ASCA-accredited testing lab can include a declaration of conformity as part of a premarket submission to the FDA. Read More
Submissions should information from the reference product’s labeling on the proposed conditions of use, along with “appropriate modifications.” Read More
Lung transplants are seen as the highest standard for patients in end-stage pulmonary failure as a result of pulmonary fibrosis, COPD or other lung diseases. Read More