The 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[…]
Final 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[…]
Final 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[…]
From 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,[…]
Two 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[…]
From the FDA: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Preclinical Assessment of Investigational[…]
The FDA approved 35 new drugs in the fiscal year ending Sept. 30 (FY2012), the same number of drugs that were approved in FY2011, according[…]
From Morbidity and Mortality Weekly Report (MMWR) To highlight the importance of annual influenza vaccination, and to foster greater use of influenza vaccine in the[…]
In January 2011, the FDA announced a Plan of Action to modernize and improve the FDA’s premarket review of medical devices. In the two years[…]
Two new draft guidance documents have been posted on the Clinical Trials Guidance Documents page, http://www.fda.gov/RegulatoryInformation/Guidances/ucm240323.htm. IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy[…]