France – Sérialisation: vers une pénalité trimestrielle et reconductible de 2.000€ pour les officinaux
PARIS (TICpharma) - Le gouvernement envisage une pénalité financière trimestrielle et reconductible de 2.000€ pour les pharmaciens d'officine qui contreviennent à leurs obligations en...
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 finalizes enforcement policy for FMT treatments
In a newly finalized guidance, the US Food and Drug Administration (FDA) laid out its criteria for applying enforcement discretion for new fecal microbiota...
UK – NHS fast tracks life-extending prostate cancer drug to patients
Around 9,000 men with one of the most advanced forms of prostate cancer will be eligible for a new life-extending treatment thanks to a...
International – ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
The objective of this guideline is to recommend acceptable amounts for residual solvents in
pharmaceuticals for the safety of the patient. The guideline recommends use...
UK – Bristol Myers Squibb’s Opdivo recommended by NICE for rare gastroesophageal cancers
Specifically, NICE’s recommendation is extended to patients with untreated HER2-negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma if the tumours express PD-L1...
USA – mRNA technology for universal flu vaccine shows early promise in US study
The World Health Organization cites vaccination as the current principal means of reducing or counteracting influenza mortality and morbidity burden, but the constantly evolving...
Europe – AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment
The recommendation is specifically for adults with the immune-mediated inflammatory bowel disease, for whom conventional or biologic treatments cannot be tolerated, or for those...
Europe – DARWIN EU® welcomes first data partners
EMA has selected the first set of data partners to collaborate with DARWIN EU®, the Data Analysis and Real-World Interrogation Network. The data available to these...
USA – FDA’s top 10 tips to transition your COVID-19 products
During the COVID-19 pandemic, the US Food and Drug Administration (FDA) allowed more than 4,000 medical devices and diagnostics on the market under emergency...
