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...
Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement providing updated public health considerations on the...
UK – Bristol Myers Squibb’s acute myeloid leukaemia oral maintenance therapy recommended by NICE
The recommendation is specifically for use in patients who have achieved complete remission or complete remission with incomplete blood count recovery following induction therapy...
France – HAS : Covid-19 – un avis global sur les vaccins bivalents mi-septembre
L’Agence européenne des médicaments (EMA) vient de modifier les autorisations de mise sur le marché (AMM) accordées aux vaccins à ARN messager développés par...
USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of...
Europe – EU adopts 10-part workplan to guide the acceleration of clinical trials
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have adopted ten priorities as part of a...
USA – House report finds Trump officials sought to influence FDA during COVID pandemic
Officials in the Trump administration pressured the US Food and Drug Administration (FDA) during the first year of the COVID-19 pandemic to make regulatory...
USA – FDA allows sponsors to spread out costs in revised IND charging guidance
The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for...
