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 ...

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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.  ...

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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 ...

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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 ...

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