Drugs - Aug/Sep 2018

September 4, 2018

 

  • International - ICH Guidelines Implementation

  • Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018

  • China - CDE Notification on Issuance of the General Requirements for the Production Scales of Generic Drug Registration Batches (Trial)

  • Japan - Notice: PSEHB/PED: Q&A on Guideline of Drug Interactions for Pharmaceutical Development and Information Provision, 23-Jul-2018

  • Canada - Notice of Compliance Information for Medicinal Products (NOC), Jun-2018

  • European Union - Pediatric Decision History: PALEXIA and Associated Names, YANTIL and Associated Names and TAPENTADOL and Associated Names (tapentadol (hydrochloride))

  • European Union - Pediatric Decision History: dopamine

  • United Kingdom - MHRA: Guidance Note No. 8: A Guide to What is a Medicinal Product

  • United Kingdom - United Kingdom - MHRA: A Consultation on Implementing ‘Safety Features’ under the Falsified Medicines Directive 

  • Brazil - Medical Devices Regulatory Framework

  • Saudi Arabia - MDS-G26: Guidance of Requirements for Preliminary Products Importation for the Purpose of Local Manufacturing of Medical Devices, Version 1.0

  • USA - Federal Register: Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for comments

  • USA - Federal Register: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Guidance for Industry; Availability (Notice of availability)

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