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Marathon’s regulatory efforts centered on gaining FDA approval of New Drug Applications (NDA) or Biologic License Applications (BLA). [7] The company provided assistance for eligible patients with financial hardship [8] and helped patients secure other assistance through the National Organization of Rare Disorders (NORD) and similar patient ...
The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
Priority review vouchers are currently earned by pharmaceutical companies for the development and approval of drugs treating neglected tropical diseases, rare pediatric diseases, and "medical countermeasures" for terrorism. The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Baxter International Inc. is an American multinational healthcare company with headquarters in Deerfield, Illinois. [2] The company primarily focuses on products to treat kidney disease, and other chronic and acute medical conditions. The company had 2017 sales of $10.6 billion, across two businesses: BioScience and Medical Products.
The Illinois Policy Institute said such an idea is bad for business. "This could create the highest tax on businesses in the country and further damage the state economy," the group said in a ...
The approval time for NDAs in the 8 years before the implementation of PDUFA I was roughly 31.3 months. During this period, the approval time exceeded 30 months in every year except 1990 when it was 27.7 months and 1992 when it was 29.9 months. From 1993 through 1996, the average approval time fell to 20.8 months.