• Pediatric
  • Priority review vouchers are currently earned for drugs treating neglected tropical diseases, rare pediatric diseases, and "medical countermeasures" for terrorism. (wikipedia.org)
  • The statute authorizes the FDA to award a priority review voucher to the sponsor (manufacturer) of a newly approved drug or biologic that targets a neglected tropical disease or a rare pediatric disease. (wikipedia.org)
  • 1993
  • The foreign policy of the Bill Clinton administration was the foreign policy of the United States from 1993 to 2001 under the Administration of President Bill Clinton. (wikipedia.org)
  • 1990 The Anabolic Steroids Act, passed as part of the Crime Control Act of 1990, which placed anabolic steroids into Schedule III The 1993 Domestic Chemical Diversion and Control Act (effective on April 16, 1994) in response to methamphetamine trafficking. (wikipedia.org)
  • 2016
  • https://www.gpo.gov/fdsys/pkg/FR-2016-12-14/pdf/2016-29941.pdf Code of Federal Regulations, 2012-04-01 The first 8 items in the temporary section of the schedule shown on the DEA website are not included here because they are duplicates of entries in the tables above. (wikipedia.org)
  • In August 2016 the DEA reaffirmed its position and refused to remove Schedule I classification. (wikipedia.org)
  • company's
  • Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for suvorexant, the company's investigational insomnia medicine, has been accepted for standard. (thestreet.com)
  • FDA determines within 45 days of the drug company's request whether a priority or standard review designation will be assigned. (wikipedia.org)
  • Economists at Duke University, who published on this concept in 2006, estimated that priority review can cut the FDA review process from an average of 18 months down to six months, shortening by as much as a full year the time it takes for the company's drug to reach the market. (wikipedia.org)
  • similarly
  • Because ibogaine is one of the many drugs that are partly metabolized by the cytochrome P450 complex, caution must be exercised to avoid foods or drugs that are similarly metabolized by CP450, in particular foods containing bergamottin or bergamot oil, such as grapefruit juice. (wikipedia.org)
  • cannabis
  • The US government, on the other hand, maintains that cannabis is dangerous enough to merit Schedule I status. (wikipedia.org)
  • Subsequently, medical cannabis advocacy group Americans for Safe Access filed an appeal, Americans for Safe Access v. Drug Enforcement Administration in January 2012 with the District of Columbia Circuit, which was heard on 16 October 2012 and denied on 22 January 2013. (wikipedia.org)
  • In 1970, Congress placed cannabis into Schedule I on the advice of Assistant Secretary of Health Roger O. Egeberg. (wikipedia.org)
  • In 1972, the National Commission on Marijuana and Drug Abuse released a report favoring decriminalization of cannabis. (wikipedia.org)
  • Jon Gettman, former director of the National Organization for the Reform of Marijuana Laws, has argued that cannabis does not fit each of the three statutory criteria for Schedule I. Gettman believes that "high potential for abuse" means that a drug has a potential for abuse similar to that of heroin or cocaine. (wikipedia.org)
  • Under the CSA, the Drug Enforcement Administration classifies cannabis as a Schedule I drug, determined to have a high potential for abuse and no accepted medical use - thereby prohibiting its use for any purpose. (wikipedia.org)
  • Cannabis was commonly sold in tincture form by Parke-Davis, Eli Lilly, E. R. Squibb & Sons, and other drug manufacturers. (wikipedia.org)
  • By the end of the 19th century, the use of cannabis in medicine had declined due to a number of factors, including difficulty in controlling dosages and the rise in popularity of synthetic and opium-derived drugs. (wikipedia.org)
  • The advent of the hypodermic syringe also allowed these drugs to be injected for immediate effect, in contrast to cannabis which is not water-soluble and therefore cannot be injected. (wikipedia.org)
  • Additionally, as fears regarding the recreational use of cannabis began to take hold (prompted by sensationalist media reports and government propaganda campaigns), states began passing legislation to restrict the sale and possession of cannabis, eliminating its availability as an over-the-counter drug. (wikipedia.org)
  • however, it also had the effect of severely curtailing medical use of the drug, due to new fees and regulatory requirements put in place that imposed a significant burden on doctors prescribing cannabis. (wikipedia.org)
  • Title II, Part F of the Comprehensive Drug Abuse Prevention and Control Act of 1970 established the National Commission on Marijuana and Drug Abuse-known as the Shafer Commission after its chairman, Raymond P. Shafer-to study cannabis abuse in the United States. (wikipedia.org)
  • dose
  • Collectively, these findings suggest that the D2 receptor is not necessary for cocaine self-administration, but this receptor subtype is involved in mechanisms that limit rates of high-dose cocaine self-administration. (jneurosci.org)
  • The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug, which may permit dose intensification and/or an increase in the cumulative dose that may be administered, resulting in enhanced efficacy. (clinicaltrials.gov)
  • LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate. (clinicaltrials.gov)
  • At least three patients will be studied at each dose level and at least three patients will complete one 21-day course before any patient is enrolled at the next dose level. (clinicaltrials.gov)
  • The preclinical stages are also necessary to determine approximate dose ranges and proper drug formulations (i.e., tablet, injection etc…) This is also the stage in which the drug candidate may be first tested in laboratory animals prior to moving to the phase one trials. (wikipedia.org)
  • dosage
  • Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria and "cocktail" mix. (wikipedia.org)
  • Vaccine escalation studies aim to minimize chances of serious adverse effects (SAE) by slowly increasing the drug dosage or frequency. (wikipedia.org)
  • treaties
  • this quote needs a citation] Rufus King notes that this stratagem was similar to that used by Harry Anslinger when he consolidated the previous anti-drug treaties into the Single Convention and took the opportunity to add new provisions that otherwise might have been unpalatable to the international community. (wikipedia.org)
  • classification
  • His letter to Harley O. Staggers, Chairman of the House Committee on Interstate and Foreign Commerce, indicates that the classification was intended to be provisional: Dear Mr. Chairman: In a prior communication, comments requested by your committee on the scientific aspects of the drug classification scheme incorporated in H.R. 18583 were provided. (wikipedia.org)
  • statutory
  • While not specifically related to clinical trials, the Council also recommended that FDA "make full use of accelerated approval for all drugs meeting the statutory standard of addressing an unmet need for a serious or lifethreatening disease, and demonstrating an impact on a clinical endpoint other than survival or irreversible morbidity, or on a surrogate endpoint, likely to predict clinical benefit. (wikipedia.org)
  • compounds
  • 1 ). In the sections that follow, we briefly describe key aspects of the Agents Developmental Pathway that present particular challenges or require improvement in design or implementation, so as to improve the efficiency of bringing new compounds to the clinic as drugs for human testing. (aacrjournals.org)
  • successfully
  • Operator Testing and Mentoring - New operators must successfully complete a written test before being permitted to purchase insurance. (wikipedia.org)
  • New operators must successfully complete mentoring under the guidance of an experienced operator during their first rail excursion. (wikipedia.org)
  • toxicity
  • Understanding vaccine safety and the immunological response to the drug, such as toxicity, are necessary components of the preclinical stage. (wikipedia.org)
  • herbal
  • As traditional medical treatment revolves around drug therapy, traditional Chinese medicine herbal remedies are the most common alternative treatment for tetanus. (encyclopedia.com)
  • placebo
  • After the administration of the vaccine or placebo, the researchers collect data on antibody production, on health outcomes (such as illness due to the targeted infection or to another infection). (wikipedia.org)
  • cocaine
  • However, it has been difficult to differentiate the roles of the D2-like receptor subtypes in the behavioral effects of cocaine because of the relatively low selectivity of drugs for D2, D3, and D4 receptors in vivo . (jneurosci.org)
  • First, we evaluated cocaine self-administration behavior, and related effects of nonselective D2-like drugs, in mutant mice that lack the D2 receptor but express D3 and D4 receptors. (jneurosci.org)
  • In wild-type mice, pretreatment with the D2-like antagonist eticlopride increased rates of self-administration of high doses of cocaine, and the D2-like agonist quinelorane served as a positive reinforcer when substituted for cocaine. (jneurosci.org)
  • Next, we compared the effects of novel antagonists selective for different D2 receptor subtypes on cocaine self-administration behavior in outbred rats. (jneurosci.org)
  • In rats, a D2 selective antagonist increased rates of self-administration of high doses of cocaine and also combinations of cocaine and the D2-like agonist quinelorane, whereas D3/D4 antagonists were ineffective. (jneurosci.org)
  • Our results also suggest that D3 and D4 receptors do not play major roles in the modulation of cocaine self-administration by D2-like drugs. (jneurosci.org)
  • Thus, several lines of evidence suggest a prominent role for dopamine receptors in cocaine self-administration behavior. (jneurosci.org)
  • indications
  • The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a fee (approximately $2.8 million) to use the voucher. (wikipedia.org)
  • Phase
  • In 2012, the President's Council of Advisors on Science and Technology (PCAST) recommended that FDA "run pilot projects to explore adaptive approval mechanisms to generate evidence across the lifecycle of a drug from the premarket through the postmarket phase. (wikipedia.org)
  • Phase two will consist of more healthy volunteers in the vaccine target population (~100s of people) to determine reactions in a more diverse set of humans and test different schedules. (wikipedia.org)
  • reactions
  • Recent scientific advances have helped to use transgenic animals as a part of vaccine preclinical protocol in hopes to more accurately determine drug reactions in humans. (wikipedia.org)
  • medical
  • An adaptive clinical trial is a clinical trial that evaluates a medical device or treatment by observing participant outcomes (and possibly other measures, such as side-effects) on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations. (wikipedia.org)
  • Designation of a drug as "priority" does not alter the scientific/medical standard for approval or the quality of evidence necessary. (wikipedia.org)
  • include
  • Traditional opponents to U.S. investment policy such as Public Citizen decried the 2012 Model BIT, criticizing the Obama Administration for failing to include strong enough labor and environment protections and for preserving the ability of US and foreign businesses to initiate "investor-state" arbitrations. (hoganlovells.com)
  • It will for example include a new calendar and further improvements of the mobile template. (wikipedia.org)
  • safety
  • Approximately 100 patients will be needed to complete collection of 26 weeks of safety data, and approximately 50 patients will be needed to complete collection of 52 weeks of safety data. (businesswire.com)
  • This is granted when a drug is intended to treat a serious condition and would "provide a significant improvement in safety or effectiveness" over currently available treatments. (wikipedia.org)
  • The purpose of screening the receiving parties of finished goods is to exude "due diligence" and "reasonable care" when completing transactions with foreign entities, ensuring the safety and intention of the products and importers. (wikipedia.org)
  • Treatment
  • It is used as an alternative medicine treatment for drug addiction in some countries. (wikipedia.org)
  • The priority review voucher program is a program that grants a voucher for use of priority review to a drug developer as an incentive to develop treatments for drugs that might otherwise not be profitable to develop because of a smaller pool of patients needing treatment. (wikipedia.org)
  • A priority review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. (wikipedia.org)
  • The distinction between priority and standard review times is that additional FDA attention and resources will be directed to drugs that have the potential to provide significant advances in treatment. (wikipedia.org)
  • It eliminated mandatory minimum sentences and provided support for drug treatment and research. (wikipedia.org)
  • routine
  • Medikamente zur postoperativen Schmerztherapie: Bewährtes und Neues" [Drugs for postoperative analgesia: routine and new aspects: Part 2: opioids, ketamine and gabapentinoids]. (wikipedia.org)
  • high
  • A vaccine candidate drug is first identified through preclinical evaluations that could involve high throughput screening and selecting the proper antigen to invoke an immune response. (wikipedia.org)
  • potential
  • The actual and potential harm of use of the drug is not great enough to justify intrusion by the criminal law into private behavior, a step which our society takes only with the greatest reluctance. (wikipedia.org)
  • available
  • It was widely available in pharmacies and even grocery stores during the latter half of the 19th century, priced affordably relative to other drugs with no requirement for a doctor's prescription. (wikipedia.org)
  • months
  • Negotiators from China, Japan, and Korea reportedly have completed negotiations on a tripartite investment treaty, and the treaty text is expected to be released in the coming months. (hoganlovells.com)
  • An adaptive trial design enabled two experimental breast cancer drugs to deliver promising results after just six months of testing, far shorter usual. (wikipedia.org)
  • Vaccine trials may take months or years to complete, since a sufficient time period must elapse for the subjects to react to the vaccine and develop the required antibodies. (wikipedia.org)
  • The FDA goal for completing a priority review is six months. (wikipedia.org)
  • Under current Prescription Drug User Fee Act targets, the FDA aims to complete and act upon reviews of priority drugs within six months instead of the standard ten-month review period. (wikipedia.org)
  • Company
  • A priority review voucher can be used when a drug does not fit these requirements, but the company wishes to expedite the review process. (wikipedia.org)
  • The act built upon the tropical disease system and made amendments including a shorter notification to the FDA before exercising a voucher, a designation system so that early in the drug development cycle sponsors may use the possibility of earning a voucher in their valuation of their company, a requirement of a marketing plan and reporting of marketing, and indefinite transferability of the voucher. (wikipedia.org)
  • A request for Priority Review must be made by the drug company. (wikipedia.org)
  • Status
  • Priority review status can apply both to drugs that are used to treat serious diseases and to drugs for less serious illnesses. (wikipedia.org)
  • physician
  • It was popularized in Western medicine by the Irish physician William Brooke O'Shaughnessy, who was introduced to the drug in the 1830s while living abroad in India. (wikipedia.org)
  • early
  • Clinical studies of ibogaine to treat drug addiction began in the early 1990s, but concerns about cardiotoxicity led to termination of those studies. (wikipedia.org)
  • The nation first outlawed addictive drugs in the early 1900s and the International Opium Convention helped lead international agreements regulating trade. (wikipedia.org)
  • approval
  • When seeking approval for a drug, manufacturers can apply to the FDA for priority review. (wikipedia.org)
  • Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. (wikipedia.org)
  • prescription
  • The petition was ultimately denied after 22 years of court challenges, but a pill form of cannabis's psychoactive ingredient, THC, was rescheduled in 1985 to allow prescription under schedule II. (wikipedia.org)
  • In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times - standard review and priority review. (wikipedia.org)