USA – Industry clamors for clarity on FDA’s advanced manufacturing designation program
Industry is welcoming FDA’s upcoming advanced manufacturing technologies (AMT) program but is clamoring for more clarity on crucial details like what methods will be...
Europe – Environmental risk assessment of medicinal products for human use
It is mandatory for a marketing authorisation application (MAA) for a medicinal product for human use (HMP) to include an environmental risk assessment (ERA)....
Europe – Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT...
USA – FDA proposes rule for difficult-to-compound drugs, drug categories
The US Food and Drug Administration (FDA) is proposing the creation of two lists of drugs or drug categories that are difficult to compound...
UK – New treatment option available today for womb cancer
540 adults will have access to Dostarlimab (also called Jemperli and made by GSK). Dostarlimab is a monoclonal antibody and helps the immune system...
Europe – EU pharmaceutical policy: MEPs support comprehensive reform
On Tuesday, the Environment, Public Health and Food Safety Committee adopted its position on the new directive (66 votes in favour, two against and...
USA – FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic...
Europe – European Parliament committee proposes changes to pharma legislation
The European Parliament’s health committee is set to debate and vote on changes to the proposed pharmaceutical legislation on 19 March, including provisions that...
USA – FDA offers guidance on minor label changes for OTC drugs
The US Food and Drug Administration (FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance...
Europe – EU regulators and industry clash on pharmaceutical reform package
European Union officials said a proposal to reform the EU pharmaceutical legislation will go a long way towards providing equal access to new medicines,...
