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RSS FeedPosted by Michael Wonder on 21 Jul 2020
Use of risk evaluation and mitigation strategies by the US Food and Drug Administration, 2008-2019
21 July 2020 - The US FDA Amendments Act of 2007 gave the FDA authority to require a Risk Evaluation and ...
Posted by Michael Wonder on 04 Apr 2019
FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy plans and to making sure they do not impede generic drug development
4 April 2019 - Today, the U.S. FDA issued guidance for industry, REMS: FDA’s Application of Statutory Factors in Determining When ...
Posted by Michael Wonder on 05 Feb 2019
Risk classification of antimicrobials used in animals opens for public consultation
5 February 2019 - EMA has published today for public consultation its updated scientific advice on the categorisation of antimicrobials. ...
Posted by Michael Wonder on 24 Jan 2019
FDA statement from Commissioner announcing efforts to improve the quality of the information used to assess the effectiveness of REMS programs in supporting the safe use of medications
24 January 2019 - In making decisions about whether the benefits of a drug outweighs its risks, there are many ...
Posted by Michael Wonder on 11 Jan 2018
Black Triangle Scheme - information for sponsors
11 January 2018 - The eligibility of a product for inclusion in the scheme will be considered in the Risk Management ...