Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.
The US Food and Drug Administration (FDA) is informing stakeholders and the public that it will soon begin implementing a court decision that may require the agency to transition some products approved as drugs to be regulated as devices.
In a major shift, and a big win for the pharmaceutical industry, the FDA said Friday that moving forward it intends to regulate products that meet both the device and drug definitions as devices.
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration (FDA) approved TAGITOL V (barium sulfate) oral suspension for use in adult patients undergoing a CTC.
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved VARIBAR NECTAR (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders.
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for READI-CAT® 2 and READI-CAT® 2 SMOOTHIE (barium sulfate) oral suspension for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients. This is the second regulatory approval of a barium-based contrast agent in the U.S., and the first for use in modern CT imaging making Bracco the only company with FDA-approved barium based contrast agents.
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