USA – Dems urge free OTC birth control while GOP fights to ban mail-order...
US Democratic senators have signed a letter to the Biden administration to issue guidances that ensure Perrigo’s over-the-counter birth control pill Opill (norgestrel) is...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023
GLP-1 receptor agonists: available evidence not supporting link with thyroid cancer
EMA’s safety committee (PRAC) has concluded that the available evidence does not support a...
UK – Novartis’ Cosentyx recommended by NICE for hidradenitis suppurativa
The recommendation, which makes Cosentyx the first biologic treatment for HS since 2016, specifically applies to patients who have had an inadequate response to...
USA – FDA addresses use of remote interactive evaluations in post-pandemic era
Draft guidance from the US Food and Drug Administration (FDA) outlines the agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics facilities...
Europe – EMA takes further steps to address critical shortages of medicines in the...
Today, EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to...
International – ICH releases Q9 training materials on quality risk management
The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the...
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...
