USA – Industry experts tout potential for master protocols in pediatric clinical trials
Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according...
USA – FDA issues emergency guidance to spur development of monkeypox tests
The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics...
USA – FDA drafts guidance on pediatric clinical pharmacology studies
The US Food and Drug Administration (FDA) has laid out its thinking on the ethical and physiological issues sponsors should consider when planning to...
Europe – COVID-19 vaccines safety update
The safety of authorised COVID-19 vaccines is continuously monitored, and updated information is regularly provided to the public.
Safety updates outline the outcomes from assessments...
UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment
NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an...
Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for...
General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021....
Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in...
Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have...
Europe – New general chapter on implementation of pharmacopoeial procedures published in the 11th...
A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted...
Europe – 11th edition of the European Pharmacopoeia now available in print
The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available in print version.
This latest edition contains numerous revised and new texts, reflecting...
International – Pharma groups question enhanced approach in Q14, call for more alignment between...
Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced...
