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FDA - Risk Management Plans to Mitigate the Potential for Drug Shortages
Drug shortages pose a significant public health threat as they can delay, and in some cases, even...
19
US Generic Drug User Fee
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 This guidance...
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017
This guidance...
16
FDA Revises 2006 Guidance: Investigating Out-of-Specification Test Results for Pharmaceutical Production
FDA announces revisions to the 2006 guidance “
EMA public consultation - Remote QP Batch Certification
Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to...
le ultime news
16 Mar
Registrazione attività di fabbricazione e/o importazione di sostanze attive ad uso veterinario da parte di officine di fabbricazione operanti prima del 28 gennaio 2022
14 Mar
EU Firms Up Plans For Unitary Supplementary Protection Certificates for pharmaceutical and plant products
11 Mar
UK MHRA Inspectorate - “Compliance Monitor process (Part 1) – An introduction”
US FDA - Continue Pressing To Conduct Surprise In-Person Inspections
09 Mar
FDA Invites Comments on Quality Metrics
08 Mar
AIFA - Questions & Answers sui processi autorizzativi relativi a procedure Nazionali, di Mutuo Riconoscimento e Decentrate
Crisi Ucraina, aziende farmaci generici: 'massima criticità approvvigionamenti in Europa'
07 Mar
Conflitto Russia-Ucraina e Horizon Europe
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