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News from the world

21

Mar

EU pharmaceutical policy: MEPs support comprehensive reform

MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.

  • Promoting innovation and access to affordable medicinal products

  • Specific rules for novel medicines such as orphan drugs and antimicrobials

  • Medicines to become more environmentally sustainable

[Press release European Parliament]

20

Mar

Riforma farmaceutica: il Parlamento Ue non tocca (quasi) i tempi della tutela regolatoria

Nuovo codice del farmaco europeo: il Parlamento Ue potrebbe accettare di estendere a 7,5 anni la tutela...

15

Mar

US FDA Final Guidance: Controlled Correspondence Related to Generic Drug Development

FDA is committed to ensuring current and prospective abbreviated new drug application (ANDA) applicants...

15

Mar

FDA publishes artificial intelligence paper

FDA published its new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH,...

14

Mar

Intelligenza artificiale: il Parlamento europeo ha approvato l’Ai Act

Il traguardo è per certi versi storico e rappresenta un punto di svolta lungo il cammino dell’Unione...

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