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CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH by David N. Muchemu

CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH David N. Muchemu ebook
Format: pdf
Publisher: Authorhouse
ISBN: 9781434314673
Page: 148

Amidst amplified interest in, and enforcement efforts of, data security practices by multiple federal agencies, three regulators are collaborating to determine standards across all industries. A range of stakeholders (e.g., Bio-Pharmaceutical companies, CROs) and disciplines (e.g., clinical operations, biostatistics, data management, regulatory affairs and quality management) to work with representatives from the FDA. Apr 25, 2014 - What You NIST to Know About Upcoming Regulation of Data Security by the ONC, FDA and FCC. Dec 11, 2013 - Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. Apr 25, 2013 - This working group will discuss ways to incorporate the site selection tool data set variables into existing standards and identify potential standardized methods for both the industry and FDA to develop the data sets in the specified format. Jul 1, 2013 - We contend that precautionary regulation should provide an incentive to generate better data and recommend adopting a pragmatic, but scientifically better founded approach to mixture risk assessment. The Office of the NIST guidance for information security includes detailed instructions on how organizations are expected to approach risk management. These provisions of the House discussion draft would take what is arguably the most fatal flaw in current TSCA – EPA's inability to regulate dangerous chemicals due to an onerous and paralyzing cost-benefit analysis requirement . New approaches are all over the map: Namely, I'm OK with heavy government regulation of drugs (in principle—I have enormous problems with how the FDA does things in practice today, but that's a separate discussion!). Mar 4, 2014 - EPA's safety determination concludes the chemical “will result in an unreasonable risk of harm to human health,” and so EPA initiates the requisite rulemaking to restrict use of the chemical. The Registration, Evaluation, Authorisation and Restriction of Chemicals (EC 1907/2006) (REACH) in June 2007, a number of extensive reviews of the literature concerning uncertainty factors were published by government agencies and industry associations [1-5].