Archives of Nursing and Care

New Chemical Entities Journal

 The new drug approval is of two phase process - the first phase for clinical trials and second phase for marketing authorization of drug. ... Thereafter, the clinical trials can be conducted (phase I to phase IV). These studies are performed to ensure the efficacy, safety and optimizing the dose of drug in human beings. According to research by J.P. Morgan, the FDA has, on average, approved 20–25 new drugs per year in the past two decades. But annual approvals in the past five years, except for a dip in 2016, have been in the range of 40–50 new drugs. What does 'FDA approved' mean? "FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use." Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval. The 30-month stay is triggered when a patent infringement action is initiated and the patent information was submitted to the FDA before the generic drug application was submitted.. Generally, the patent owner initiates a patent infringement suit by filing a complaint in a U.S. district court. The Median Cost of Bringing a Drug to Market is $985 Million, According to New Study. One of the arguments biopharma companies make for the high cost of new drugs is the expense of drug development  

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