80% new drug clinical data fraud Food and Drug Administration said it does not meet the facts-www.haole15.com

80% new drug clinical data fraud? The food and Drug Administration said does not accord with the facts at the beginning of September, a new 80% reported clinical data involving fake regulatory link layers fall behind "raised public attention. Reported that the State Food and drug administration to start the clinical trial data self verification work over the past year, found that more than 80% new drug clinical data involving fake. Recently, the food and Drug Administration of drug registration division responsible person responded that 80% new clinical data involving fake does not conform to the facts. Drug registration department of the person in charge, in July 22, 2015, the food and Drug Administration issued a notice, self-examination clinical trial data authenticity, integrity, normative requirements of the applicant to apply for listing and import 1622 registration application, the deduction from clinical trials of 193 varieties, the need for a total of 1429 varieties of self-examination. Application for registration of the clinical trial of the problem can be withdrawn from the initiative to withdraw, to improve the reporting of re. At the end of June 2016, the enterprise through self-examination active for withdrawal of 1193, accounting for 83% of the total should be self-examination. It is "83%" this data was misread. The official stressed that the corporate self-examination withdrawn for a variety of reasons, some do not conform to the quality management of clinical trials, scientific and accuracy of test results; some data is incomplete, no traceability, not enough to prove that the drug is safe and effective reporting; also some data is not true, do not rule out the possibility of intentional fraud. So we can not simply take the initiative to withdraw the company attributed to data fraud. Some media reports said, 80% new drug clinical data involving false does not conform to the facts. The aim of drug clinical trials is to determine the safety and efficacy of drugs. The possible consequence of clinical data fraud is that an adverse reaction will not occur in the specification. Specification disclosure is not exhaustive, will be a threat to the lives of patients taking drugs. Moreover, in the event of adverse reactions, it is difficult for patients to link their symptoms and taking drugs, delay treatment, rights difficulties. Drug research must be scientific, rigorous, can not have the slightest bit of false, but not deliberately fraud. The official said, to carry out self-examination and verification of clinical data, to combat data fraud, is to encourage innovation, to create a good environment for fair competition, to ensure the safety and effectiveness of drugs approved for listing. Click to join the Guangdong provincial health official group (187945286) more exciting, more benefits, it is bad for you oh相关的主题文章:

Comments are closed.