USA – FDA issues pharmacy compounding guidance due to amoxicillin shortage
Due to the current shortage of amoxicillin oral antibiotic powder for suspension, the Food and Drug Administration (FDA) has issued guidance on the preparation of...
USA – FDA outlines risk-based approach to monitoring clinical trials
The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring...
International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...
The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
Europe – EMA Management Board: highlights of October 2023 meeting
EMA’s Management Board met on 5 October in Amsterdam.
Clinical trials in the EU
The Board adopted revised transparency rules for the publication of information on clinical...
USA – FDA updates guidance on promotional labeling and advertising of biosimilars
The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products.
The...
UK – MHRA updates biosimilar guidance to allow interchangeability between products
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use...
France – Covid-19 : intégration du vaccin bivalent Spikevax® (BA.4-BA.5) dans la stratégie vaccinale
Après la validation par l’Agence européenne du médicament (EMA) du vaccin Spikevax® de Moderna le 21 octobre dernier, la HAS ajoute ce vaccin à...
Europe – New vaccine to protect people in the EU and worldwide against dengue
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...
International – Genetically modified herpes combats advanced cancers
Researchers have found that RP2 – a modified version of the herpes simplex virus – has showed signs of effectiveness in a quarter of...
Asia – 3D-printed drug advancing to clinical trials in SE Asia
Craft Health’s tailored drug technology just received a boost. The Singapore 3D printed pharmaceuticals manufacturer announced it has raised S$1.42 million ($1.03 million) in...
