Clinical (human) trials are essential to pharmaceutical companies that develop and market new drugs. They are required by the United States Food & Drug Administration (“FDA”) both prior to approval of the drug for marketing, and during post-approval marketing, as a means of evaluating the drug's safety and efficacy.
Practice Tip: Keys to Successful Negotiation of Clinical Trial Agreements
Clinical trial agreement ("CTA") negotiation has become the most common cause of delay in studies. Because the cost of bringing a new drug to market is astronomical, pharmaceutical companies typically lose millions of dollars per week as a result of any delay in the process.
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