International – Industry groups call for changes in ICH M11 guideline on harmonized protocols
In comments to the US Food and Drug Administration (FDA), pharmaceutical industry groups called for revisions to the International Council for Harmonisation’s (ICH) M11...
Europe – European Commission grants AstraZeneca three new approvals
The Imfinzi/ Imjudo approvals authorise the combination to be used for the first line treatment of adult patients with advanced or unresectable hepatocellular carcinoma...
USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year....
UK – NICE publishes final draft guidance recommending three COVID-19 treatments
This includes those who are immunosuppressed, or who have other conditions such as heart disease, respiratory disease, diabetes or neurological disorders.
The agency’s latest guidance...
USA – Guidance: FDA details ANDA PSG meetings under GDUFA III
The US Food and Drug Administration (FDA) last week issued draft guidance that details its thinking on conducting product-specific guidance (PSG) meetings with generic...
UK – AstraZeneca’s Evusheld not recommended by NICE for COVID-19 prevention
In new draft guidance, NICE explained that there is not enough evidence of Evusheld's effectiveness against current SARS-CoV-2 variants in the UK and those...
France – Les contre-indications à la vaccination contre le Covid-19
Les cas de contre-indication médicale faisant obstacle à la vaccination contre le Covid-19 et permettant la délivrance du certificat de contre-indication permettant de déroger...
Europe – Human medicines: highlights of 2022
In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 41 had a new active substance which had never been authorised in the European Union (EU)...
USA – Study: One-fifth of recent FDA approved drugs not authorized, reimbursed in other...
More than one-fifth of drugs recently approved by the US Food and Drug Administration (FDA) were not approved or recommended for public reimbursement in...
USA – Study: Extrapolation used in more than half of pediatric drug labeling changes
Some form of data extrapolation – either full or partial – was used in making more than 63% of pediatric labeling changes in the...
