conditions that do not respond to currently approved therapies. stages of development, including that of initial, phase-one testing. As an incentive, research and development companies will be allowed to charge a fee for the drugs to help cover their high costs.
Experimental drugs have been available since the 1970's, however guidelines for their use have been unclear, resulting in many patients being unaware of, or unable to gain access to treatments. "By clarifying and streamlining the processes, FDA hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them," explains Dr. Janet Woodcock, FDA's Deputy Commissioner for Operations.
receive experimental drugs. The list will include single patients in emergency and non-emergency settings, small groups of patients, and larger groups of patients involved in a treatment IND (Investigational New Drug) program. advantages over existing therapies.
Additionally, money received from sales may apply only to the direct costs of the drug's development and distribution. throughout the healthcare community. at the FDA's website.
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