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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
The PRAC starts a review of the risks with high-strength estradiol-containing creams and restricts the use of the multiple sclerosis medicine Lemtrada as a precautionary measure during the assessment of the risks with this treatment.
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The role of regulators in establishing added benefit of novel therapies
The role of regulators in establishing added benefit of novel therapies
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The role of regulators in establishing added benefit of novel therapies
The role of regulators in establishing added benefit of novel therapies
An article in Nature Reviews Drug Discovery examines the role of regulatory agencies in establishing the added therapeutic benefit of innovative treatments. The article was written by EMA’s Senior Medical Officer, Hans-Georg Eichler, Harald Enzmann, Chair of EMA’s human medicines committee (CHMP) and EMA's Executive Director Guido Rasi.
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Questions and answers on EU actions to prevent shortages due to Brexit
Questions and answers on EU actions to prevent shortages due to Brexit
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Questions and answers on EU actions to prevent shortages due to Brexit
Questions and answers on EU actions to prevent shortages due to Brexit
EMA has published a questions-and-answers document for patients, healthcare professionals, farmers and pet owners, and the general public on the preparatory work that EU authorities are doing to prevent medicines shortages due to Brexit.
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
EMA and the European Commission provide additional information to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.
