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Tag: post-marketing studies

FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors

Accelerated Approval Program, Drug, Drugs, FDA, Pediatric, post-marketing studiesFDA

On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by …

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GlaxoSmithKline to Pay $3 Billion in Settlement with Government

Drugs, Enforcement, FDA, GlaxoSmithKline, off-label promotion, off-label use, post-marketing studiesFDA

On July 2, 2012, GlaxoSmithKline (“GSK”) announced its intention to plead guilty in its ongoing healthcare fraud case in what will result in the largest settlement of its kind in the United States. In particular, the pharmaceutical giant will be …

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Recent Posts

  • FDA Halts Voluntary Cosmetic Registrations Amidst Overhauls      
  • Congress Increases Minimum Tobacco Sales Age to 21
  • FDA Warns JUUL, Alleging Marketing Violations
  • FDA Warning Letters for Alzheimer’s Supplement Claims
  • FDA Considers Changing Major Food Allergen Labeling Requirements
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