A few days ago, Luye Pharmaceutical Group announced that its new drug for the treatment of schizophrenia, risperidone sustained-release microsphere intramuscular injection (LY03004), has been approved by the US Food and Drug Administration (FDA) to submit new drugs to the United States. When applying (NDA), there is no need to submit any pediatric clinical trial plan, which means that after the approval of the listing, the pediatric clinical trial will be exempted, saving the company a large amount of money and time, and may even affect the stock price.
Since it is an application for exemption, after the exemption is successful, it is obvious that it is usually a clinical trial. Risperidone is a schizophrenia patient, which is aimed at adult medication. According to the author's many years of experience in the development of new drugs, the first reaction is that "since it is a drug for adults, there is no need to do a clinical trial for children. Is money not spent?"
According to the US Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), the FDA requires new drug applicants to submit a Pediatric Study Plan (PediatricStudyPlan) in the filing data for the NDA ( PSP), and conduct clinical trials based on PSP after the product is approved, even if the drug product claims to be applicable only to adults.
Why is it necessary to formulate such a policy? Dr. Li Xiumei, who has many years of experience in pharmaceutical research and development overseas, said: "Because of the poor development of children's medicines, the pharmaceutical companies have no motivation. In order to increase the accessibility of children's medications, the US government intervened to enact the above-mentioned bills. It is required that the research on the application of children's population should be completed within the prescribed time when the new drug is submitted for approval, so that children's medication is also scientifically guaranteed."
The key point is that what puzzles me is that even if the drug product claims to be an adult only, it must submit a pediatric research plan and conduct clinical trials. Dr. Li Zhan’s answer is very subtle: “Because it’s just a 'claim'â€, a word is awakened to the dream: “claim†is different from the actual situation. You can “claimâ€: “The new drug I developed to treat colds is for adults only,†but in reality do you have the means to ensure that doctors and parents don’t use this “claim†for adult cold medicines for children?
However, the global drug regulatory benchmark FDA is not completely one-size-fits-all. If there are sufficient reasons for the FDA to approve the application of rabbits in cases where the incidence of children is extremely low, then the therapeutic spirit of the Green Leaf Pharmaceutical Group at the beginning of this article is available. Risperidone in schizophrenia was approved for exemption from pediatric clinical trials.
Everything understands the spirit and gives the opposite. A group of friends asked: "With regard to the consistency evaluation of injections, the original research products include intravenous injection and intravenous drip. Our company only intends to apply intravenous injection, and whether it can not check the related solution with intravenous drip when doing compatibility stability. Compatibility stability."
For the time being, regardless of the use of the original drug, it is only feasible to declare the intravenous injection. A single theory, if feasible, is similar to the drug that is claimed to be used only for adults. It is also the manufacturer's instructions that “claim†is used only for intravenous injection, but the doctor may use your drug for intravenous drip with reference to the original research. The possibilities are extremely high and cannot even be avoided. Therefore, the author believes that in addition to the "intravenous" study claimed by the specification, the related research on "intravenous drip" that occurs in practical applications is still meaningful and necessary. Otherwise, a doctor did not carefully study the manufacturer's manufacturer's instructions, only based on the experience of the original research drug used in the past, who is the problem?
For many years, we have developed a habit. The rules and guidelines require us to do what we do. If the regulations do not require it, we always think about whether we can do less or not. Now we need to change from "Make me do" to "I want to do". I want to understand why this is done, form a complete chain of evidence, and first convince myself to convince drug review officials. (Li Tianquan)
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