Clinical Trials
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FDA publishes final rule regarding 21 CFR Parts 50 and 56 regulating clinical trials and children
February 28, 2013The FDA published a final amended rule in the Federal Register on 02/28/2013 concerning 21 CFR Parts 50 and 56. The effective date of this rule will be March 28th, 2013. From the posting: Summary The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of [...]
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Protections for Subjects in Human Subjects Research with Pesticides: Final Amendments to EPA’s 2006 Rule Strengthen Protections
February 22, 2013Final Amendments to EPA’s 2006 Rule Strengthen Protections On February 8, 2013, EPA Administrator Lisa P. Jackson signed amendments strengthening existing standards for human research involving pesticides submitted by third parties for consideration in EPA decision-making. The amendments apply to the portions of EPA’s 2006 rule, Protections for Subjects in Human Research (40 CFR part [...]
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European Medicines Agency updates guideline on evaluation of anticancer medicines
January 16, 2013From the EMA: 11/01/2013 The European Medicines Agency has finalised the revision of its guideline on the evaluation of anticancer medicinal products. This revision includes, amongst other topics: the use of biomarkers as an integrated part of the development of medicines; combination-therapy studie; the choice of endpoints in confirmatory trials. The Agency is responsible for [...]
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New Clinical Trials Drugs and Biologics Guidance Documents
January 8, 2013Two new “Guidance for Industry and Investigators” clinical trials documents are available from the FDA. They include: Safety Reporting Requirements for INDs and BA/BE Studies This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies [...]
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Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability
December 26, 2012From the FDA: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,” dated November 2012. The draft guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of [...]
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