Europe – EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus.
The vaccine, known as Nuvaxovid XBB.1.5, is to...
USA – FDA expands scope of off-label guidance to include presentations from reprints
The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses...
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Draft guidance from the US Food and Drug Administration (FDA) outlines the agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics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...
