Antidiarrheal drug products for over-the-counter human use; final monograph. Final rule.
(41/355)
The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) antidiarrheal drug products (to control the symptoms of diarrhea) are generally recognized as safe and effective and not misbranded. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph (TFM), and all new data and information on OTC antidiarrheal drug products that have come to the agency's attention. Also, this final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC antidiarrheal active ingredients that have been found to be not generally recognized as safe and effective. (+info)
Antiperspirant drug products for over-the-counter human use; final monograph. Final rule.
(42/355)
The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention. (+info)
Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.
(43/355)
The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes. (+info)
Effects of licence change on prescribing and poisons enquiries for antipsychotic agents in England and Scotland.
(44/355)
AIMS: To examine the effect of licence change for thioridazine at the end of 2000 on the prescription of antipsychotic drugs in England and Scotland, and investigate changes in poisons information inquiries and, for Edinburgh, poisons admissions. METHODS: Prescription data for antipsychotic drugs were obtained for England and Scotland and quarterly trends examined for 2000 and 2001. Accesses to the UK National Poisons Information Service website TOXBASE for antipsychotic products were examined for the same period. For Scotland telephone enquiry data, and admission data to the Edinburgh Poisons Unit were also evaluated. Trends in poisonings were compared with prescribing change. RESULTS: In England prescriptions for thioridazine fell rapidly in 2001 from approximately 35% of market share to less than 5%, and were replaced by risperidone, chlorpromazine and olanzapine. TOXBASE accesses fell from 39.3% of antipsychotics to 4.4%. Accesses for chlorpromazine, olanzapine and risperidone increased. In Scotland prescribing of thioridazine was similar to changes in England, but it was principally replaced by chlorpromazine. These changes were mirrored by TOXBASE accesses, telephone enquiries and in-patient admissions. The ratio of TOXBASE accesses for thioridazine to prescription numbers for the drug increased after the licence change. CONCLUSIONS: Licence change produced rapid change in prescribing behaviour within 3 months. Prescribing behaviour in England and Scotland was different. Changes in prescribing were mirrored by changes in accesses for poisons information in both England and Scotland, and in Edinburgh by hospital admissions. The increase in the ratio of TOXBASE accesses to prescriptions for thioridazine suggests doctors may have become more aware of its potential toxicity. (+info)
State initiatives on prescription drugs: creating a more functional market.
(45/355)
In response to unrelenting increases in prescription drug spending and use, many states are developing and implementing innovative policy solutions. The Reforming States Group (RSG), a nonpartisan organization of senior executive and legislative leaders from more than forty states and provinces formed in 1992, proposes a series of actions to improve the functioning of this market by introducing more explicit information on quality, effectiveness, and price and by experimental waiving of federal regulations. (+info)
Is the increasing use of evidence-based pharmacotherapy causing the renaissance of complementary medicine?
(46/355)
This brief commentary considers a possible hitherto infrequently discussed factor that might contribute to the increase in the use of complementary medicines: the difficulties of using placebo within the context of evidence-based medicine, which represents the current standard for pharmacotherapy in most western culture countries. It discusses the possibility of placebo having a similar or better benefit-risk profile compared with an active compound in some diseases, and shows three examples in which this can be concluded from a clinical trial (insomnia, allergic rhinitis, irritable bowel disease). It is proposed that complementary medicine has under these circumstances taken the place of placebo therapy. By this, the commentary does not deny (and does not discuss) the possibility of an effect of complementary medicines other than the placebo effect. However, it recognizes that complementary medicine is open to the therapeutic application of the placebo effect by using a medicine with the claim that it has worked in similar situations and may work in the actual patient, without requiring hard data showing superiority to placebo. Physicians might be more open to the use of complementary medicines for indications in which the placebo effect is high, the conventional therapy carries a risk of side-effects and the omission of treatment with a pharmacologically active compound does not result in irreversible damage. The regulators on their part should probably not require proof of effectiveness compared with placebo in controlled clinical trials. However, whenever used in this sense, the complementary medicine product must unequivocally demonstrate its safety with respect to both the ingredients and the pharmaceutical quality. This is unfortunately not always the case. (+info)
Drug registration application in China.
(47/355)
PURPOSE: This article is used to give a brief overview for people who would like to submit a drug registration application in China, or for those who would like to get a broader international drug registration perspective. METHODS: This paper concretely describes the new items in the current drug registration application through introducing following contents: qualification of the applicant, registration classification or type, the procedures for drug registration application review, the intellectual property rights concerning the pharmaceutical (drug substance and product), the process for submitting a drug registration application and the materials required in application for registration. RESULTS: From the paper, we have a comprehensive knowledge of drug registration application in China. CONCLUSIONS: The current Provision for Drug Registration is more reasonable and suitable for China's entry into WTO and further guarantee that safe and effective drugs are available to Chinese people. (+info)
Clinical pathology for preclinical safety assessment: current global guidelines.
(48/355)
Regulatory guidelines for preclinical safety assessment studies of new drugs, chemicals, and food additives exist in many large industrial countries. Current guidelines include recommendations or requirements for clinical pathology testing. Many of the testing requirements are similar for every country, but others are not. The similarities and differences among several of the guidelines are discussed, and specific instances of ambiguous or inappropriate testing requirements are cited. (+info)