Valsartan prices double after recall

International – Valsartan prices double after recall

Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a...
Information Note Nitrosamine impurities

International – WHO Revises Guidance on QMS Requirements for National Inspectorates

The World Health Organization (WHO) has revised its guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates to align with international...
ICH Updates After Singapore Assembly Meeting

International – ICH Offers Updates on Guidelines, Working Groups

In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15...
ICH Updates After Singapore Assembly Meeting

International – Guideline for Elemental Impurities Q3D(R1)

Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present...
The impact of Mutual Recognition Agreement between the European Union and the United States as of 27 June 2019 : Questions & Answers

Europe – The impact of Mutual Recognition Agreement between the European Union and...

Q1: What is in place since 1 November 2017? A1: The provisions of the agreement relating to the mutual recognition of inspections took effect on...
Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

International – Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

This article discusses the scope and purpose of the special designation for Regenerative Medicine Advanced Therapies (RMAT) created by the passage of the 21st Century Cures...
Top 9 Companies in the Diagnostics Market

International – Top 9 Companies in the Diagnostics Market

Add some market clearances; a rebranding; a merger or two; and some collaborations; and you’ve got a recipe for some of the most powerful...
Information Note Nitrosamine impurities

International – WHO Consults on QMS Guideline for Regulators

The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national...
Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States

International – Questions & Answers on the impact of Mutual Recognition Agreement between the...

Q1: What is in place since 1 November 2017? A1: The provisions of the agreement relating to the mutual recognition of inspections took effect on...
9 nouveaux étalons de référence de la Ph. Eur. et 20 lots de remplacement libérés en novembre 2019

International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments

La Direction européenne de la qualité du médicament & soins de santé (EDQM) et l’ANVISA, l’agence brésilienne de surveillance sanitaire, ont annoncé aujourd’hui avoir...

NOS PROCHAINES FORMATIONS