Europe – EU issues long-awaited GMP Annex 1 revision
The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years...
USA – Omnibus brings new advanced manufacturing programs to FDA
The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing...
USA – DSCSA: New interoperability ‘blueprint’ released
With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a...
UK – NICE recommends PTC Therapeutics’ Translarna reimbursement
PTC Therapeutics has announced that the National Institute for Health and Care Excellence (NICE) has issued a final evaluation document recommending Translarna.
It involves reimbursement...
France – Fiche bon usage des médicaments antiémétiques dans le traitement symptomatique des nausées...
Les médicaments à base de dompéridone (Motilium®, Peridys®, Oroperidys®), métoclopramide (Anausin Metoclopramide®, Primperan®, Prokynil L.P) ou métopimazine (Vogalène®, Vogalib®)et leurs génériques ont une...
USA – FDA issues guidance on developing long-acting local anesthetics
The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect...
Canada – Guidance : Nitrosamine impurities in medications
This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to...
USA – FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies
The US Food and Drug Administration (FDA) on Tuesday issued final guidance on the use of whole slide imaging in nonclinical toxicology studies. The...
USA – FDA proposes updated medtech RWE guidance
The US Food and Drug Administration (FDA) has updated it’s guidance on how real-world data (RWD) can be used to provide real-world evidence (RWE)...
International – ICH M11 guideline, clinical study protocol template and technical specifications
The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a...
