USA – Legal expert: FDA inspections will start looking at DSCSA compliance
Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes...
USA – FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19...
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect...
UK – MHRA safety review of medicines containing pseudoephedrine
Pseudoephedrine is used for the symptomatic relief of coughs, colds and allergies. Pseudoephedrine has been used in the UK for decades in millions and...
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UK – NICE publishes final draft guidance recommending three COVID-19 treatments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The US Food and Drug Administration (FDA) last week issued draft guidance that details its thinking on conducting product-specific guidance (PSG) meetings with generic...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In new draft guidance, NICE explained that there is not enough evidence of Evusheld's effectiveness against current SARS-CoV-2 variants in the UK and those...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...
