Gauge Regulator Opinion On Aspects Of Pharmacovigilance As It Relates To The Oncology Drug Approval Process.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c49710) has announced the addition of "Regulator regulator, n the mechanical part of a gas delivery system that controls gas pressure that allows a manageable flow of drug vapor to escape. regulator see reducing valve. Perceptions in Cancer - Evolving Opinions about the Oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. Drug Approval Process" to their offering. The oncology therapy area is unlikely to be spared from the heightened conservatism currently sweeping the regulatory environment. This is evidenced by the increased scrutiny with which the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. appraises accelerated approval applications, particularly in light of the 2005 withdrawal of AstraZenecas Iressa. Scope of this title: - Examine the function and process of EU and US regulatory advisory committees and the dynamics of their relationship with the FDA or EU Commission. - Regulator perceptions on the evolution of endpoint designation and clinical trial design for oncology drugs. - Opinions on biomarker biomarker /bio·mark·er/ (bi´o-mahr?ker) 1. a biological molecule used as a marker for a substance or process of interest. 2. tumor marker. bi·o·mark·er n. 1. validation in the development of novel cancer treatments. - The impact of the increasingly more conservative regulatory environment on accelerated approvals in oncology. Highlights of this title: The FDAs accelerated approval program is under intense scrutiny following the Vioxx debacle and the market withdrawal of AstraZenecas Iressa. Developers need to be cognizant cog·ni·zant adj. Fully informed; conscious. See Synonyms at aware. [From cognizance.] Adj. 1. of the fact that seeking regulatory approval via this expedited route may be come increasingly more challenging. The identification and validation of more robust and reliable surrogate endpoints  It has been suggested that Surrogate markers, Surrogate end point be merged into this article or section. will help streamline and expedite ex·pe·dite tr.v. ex·pe·dit·ed, ex·pe·dit·ing, ex·pe·dites 1. To speed up the progress of; accelerate. 2. the drug development process, possibly even negating the need for cumbersome and slow-to-recruit post-marketing studies for drugs that have realized accelerated approval. Regulators are enthusiastic about adaptive clinical trial designs that employ novel statistical approaches to help drive efficiencies in the oncology drug development process. Reasons to order your copy: - Gauge regulator opinion on aspects of pharmacovigilance as it relates to the oncology drug approval process. - Ascertain regulator receptiveness to innovations in oncology clinical trial design and endpoint designation. - Determine what other kinds of restructuring, in terms of legal and regulatory rules, would help drive efficiencies in oncology drug development. For more information, visit http://www.researchandmarkets.com/reports/c49710 |
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