Mon premier blog

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

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!). Submitted an environmental assessment (7) for AquAdvantage salmon to the FDA's Center for Veterinary Medicine as part of their request for deregulation. In recognition of this fact, the European Commission today adopted a Communication on the Second Regulatory Review on Nanomaterials, which also. 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]. Has On 25 August 2010, Aqua Bounty Technologies, Inc. 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. FDA currently regulates medical devices as one thing with one risk assessment, be it an embedded system medical device like a blood gas analyzer or a system made up of many components like a patient monitoring Only a legislative change will enable FDA to mandate the reporting of “near misses. Therefore, rather than putting all nanomaterials in one basket, a case-by-case approach to risk assessment should be applied, using strategies based on indications of potential risks, either in terms of exposure or hazard. Sep 30, 2013 - The workgroup recommends that HIT be regulated based on whether the use of the products represent any risk to patients or users (a risk-based approach). 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. Oct 16, 2010 - The first generations of AquAdvantage salmon had body malformations at a higher incidence than in wild type controls, but later generations had rates similar to control salmon (7). Today's REACH is best framework for nanomaterials management.