CDER Outlines Drug Safety Priorities

USA – CDER Outlines Drug Safety Priorities

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released a new report on drug safety priorities...
Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

Europe – Renforcement de la coopération entre les pharmacopées européenne et indienne

L’EDQM/la Pharmacopée Européenne (Ph. Eur.) et la Commission indienne de Pharmacopée (IPC) ont organisé à Bombay un symposium sur le contrôle qualité des médicaments dans...
Implementing the Falsified Medicines Directive: Safety Features

UK – Implementing the Falsified Medicines Directive: Safety Features

How the Falsified Medicines Directive works The EU Falsified Medicines Directive (2011/62/EU) (FMD) was adopted in 2011 and introduced new harmonised measures to ensure that medicines in...
EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines and biologicals

Europe – EDQM welcomes WHO recommendation to discontinue innocuity test in guidelines on vaccines...

The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the...
Revised EDQM Guidelines concerning the procedure for ‘Certification of Suitability to the monographs of the European Pharmacopoeia'

Europe – ‘Certification of Suitability to the monographs of the Eur Ph’ : Revised...

Following introduction of the revised Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopeia Monographs’ (PA/PH/CEP (04) 2, 7R corr) several EDQM...
Ph. Eur. to replace Histamine Sensitisation Test (HIST) for residual pertussis toxin testing

Europe – EDQM revised guideline on Content of the dossier for chemical purity and...

The revised EDQM guideline Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6Rwill enter into force in January 2019. Changes...
Drug Sponsors Urge FDA to Think Bigger About Master Protocols

USA – Drug Sponsors Urge FDA to Think Bigger About Master Protocols

Leading drugmakers are urging the FDA to think bigger about its master protocol guidelines for clinical trials and expand beyond cancer trials. In September, the...
NICE approves Xeljanz for Ulcerative Colitis

UK – NICE approves Xeljanz for Ulcerative Colitis

Currently available treatment often involves infusions or injections, which can be unpleasant and inconvenient for patients, or sometimes stop working and prove ineffective in...
Drug pricing is pharma’s top concern in 2019

UK – Drug pricing is pharma’s top concern in 2019

The GlobalData poll suggests more than half (51%) of industry respondents think that pricing will have the greatest negative impact on the sector this...
AstraZeneca wins NICE backing for asthma injection

UK – AstraZeneca wins NICE backing for asthma injection

The UK’s cost effectiveness watchdog said in an earlier appraisal consultation document that the drug was not cost-effective, but recognised the demand for such...

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