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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]
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of ...
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.
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need.
As codified in 21 U.S.C. chapter 9 of the United States Code from the LII; As codified in 21 U.S.C. chapter 9 of the United States Code from the US House of Representatives; Federal Food, Drug, and Cosmetic Act (PDF/details) as amended in the GPO Statute Compilations collection; Color Additive Status List; Food Ingredients and Colors
By the beginning of the year, 11.7 million had signed up (ex-Medicaid). [44] On December 31, 2015, about 8.8 million consumers had stayed in the program. Some 84 percent, or about 7.4 million, were subsidized. [45] Bronze plans were the second most popular in 2015, making up 22% of marketplace plan selections.