USA – FDA finalizes guidance on considerations for evaluating drug’s benefits and risks
The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into...
International – WHO releases key regulatory considerations on AI for health
The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the...
Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic...
The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution...
UK – NICE recommends Roche’s Columvi for advanced lymphoma in UK
The National Institute for Care and Excellence (NICE) has recommended Roche’s Columvi (glofitamab) for NHS use as a treatment option for a type of...
France – FDA guidance calls for testing all alcohol-based products for methanol
The US Food and Drug Administration (FDA) issued final guidance to assist manufacturers and compounders in testing alcohol products (ethanol and isopropyl) for methanol....
USA – FDA offers guidance on development of antimicrobials for diabetic foot infections
The US Food and Drug Administration (FDA) released new draft guidance on developing antimicrobial drugs specifically intended to treat diabetic foot infection, a focused...
USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.
The CHMP adopted a positive opinion for Agamree* (vamorolone),...
UK – Guidance : Full pack dispensing of valproate-containing medicines
This is guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs). These amendments...
International – Convergence: Confusion lingers over interchangeability and switching of biosimilars
While there are some areas of general alignment on standards for accepting biosimilar applications in the US, EU and Canada, some differences are impeding...
