Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.This edition of the Newsletter also includes the recommendations from the 42nd Annual Meeting of Representatives of National Pharmacovigilance Centres participating [...]
L’actualité mensuelle de l’agence nationale de sécurité du médicament et des produits de santé. Posted on the ANSM website on 19 May 2020
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of adequately powered, randomised controlled trials, [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the [...]
Está disponível nova edição da newsletter com o resumo da informação mais recentemente publicada na área COVID-19. Posted on the Infarmed website on 13 May 2020
Na sequência de emergência de Saúde Pública de âmbito Internacional declarada pela Organização Mundial de Saúde em 30/01/2020 para infeção por SARS-CoV-2 (novo coronavírus 2019), no que se refere à realização de ensaios clínicos em Portugal, o Infarmed admite que promotores, centros de ensaio clínico e equipas de investigação considerem necessária a introdução de alterações [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung [...]
Está disponível nova edição da newsletter com o resumo da informação mais recentemente publicada na área COVID-19. Posted on the Infarmed website on 7 May 2020
Ce Comité est chargé notamment de l’évaluation des PIPs (Plans d’Investigations Pédiatriques) qui encadrent les programmes de développement en qualité préclinique et clinique des médicaments destinés à la population pédiatrique (de la naissance à 17 ans inclus), ainsi que des dérogations et reports de développement en pédiatrie. Le PDCO vérifie la réalisation du programme d’études [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.A new biological reagent is now available to labs around the UK and the world that will help them to set [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung cancer [...]
Los investigadores deben considerar la posibilidad de sumarse a estudios clínicos que ya estén en marcha antes de plantear un estudio propio Se prioriza la evaluación de ensayos clínicos en COVID-19 Los estudios observacionales de seguimiento prospectivo sin ánimo comercial serán clasificados como EPA-AS Los estudios clínicos son una herramienta indispensable para poder identificar la [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), [...]
Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate [...]