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The Federally Facilitated Marketplace is established in a state by the HHS Secretary for states that chose not to set up their own marketplace or did not get approval for one. [2] Individuals (i.e. citizens of a state) and employers will have the ability to find and purchase Qualified Health Plans through the FFM and its partners. [1]
Buparlisib was under investigation as a treatment for advanced or metastatic HER2-negative breast cancer in several phase III clinical trials: . The phase III trial BELLE-2 compared buparlisib + fulvestrant with fulvestrant alone in patients with advanced or metastatic HER2-negative, hormone receptor-positive (HR+) aromatase inhibitor-resistant breast cancer.
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
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RARITAN TOWNSHIP – Target will be coming to the Flemington Marketplace. The township Zoning Board of Adjustment has approved the proposal by REEP-RTL, owner of the shopping center just north of ...
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In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.