FDA Releases Facility Readiness Guidance
Biopharm International FDA published a final guidance document on June 18, 2024 that provides applicants with information on FDA’s policy for assigning a goal date for a facility’s inspection readiness as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, […]
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Communiqué de presse : Heva & Telemedicine Technologies signent un partenariat
Communiqué de presse Paris, le 19 juin 2024 Heva et Telemedicine Technologies signent un partenariat visant à accélérer les innovations dans la collecte et l’analyse des données de santé Convaincus du potentiel d’innovation dans les outils numériques destinés aux médecins et aux patients, Heva, filiale de Docaposte et marque de La Poste Santé & […]
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14th Meeting of the CleanWeb™ Users Club
June 18, 2024 – 2:00 PM – 3:00 PM CEST Join us for the 14th meeting of the CleanWeb™ Users Group. This webinar is free and open to all our users. This afternoon traditionally serves as an opportunity to review the latest features developed for our users and to present upcoming developments. During this webinar, […]
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Yes, Agile Can Work in Medtech
Med City News Three tips to succeed in a highly regulated environment. Medical devices take multiple years and millions of dollars to bring to market. Regulations play a huge role: medtech manufacturers must meet a range of requirements to get devices approved – or risk wasting their investment. The high cost of failure encourages many […]
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