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inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
Drug companies have argued that Medicare’s price negotiations could chill their research and development, leading to fewer new medications coming to market. This story has been updated with ...
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
President Trump rolled back a Biden administration executive order aimed at lowering prescription drug prices, including an effort to make more generic drugs available to Medicare patients for ...
Blood thinner Eliquis from Bristol Myers Squibb and Pfizer has been one of the most expensive drugs for the Medicare health system to cover, according to the Centers for Medicare & Medicaid ...
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