Europe – EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials
The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application...
Europe – EMA Management Board: highlights of March 2024 meeting
EMA annual report 2023
The Board adopted EMA’s annual report for 2023. In 2023, EMA recommended 77 medicines for marketing authorisation for human use, 39 of which...
France – Paxlovid (nirmatrelvir/ritonavir) : rappel des interactions médicamenteuses avec certains immunosuppresseurs, notamment le...
Paxlovid est indiqué dans le traitement des patients adultes atteints du Covid-19 qui n’ont pas besoin de supplémentation en oxygène et qui présentent un...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
12 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.
The CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec)...
Europe – Regulatory requirements for conditional marketing authorization ‘evolving’
Regulatory requirements for conditional marketing authorizations (CMAs) are “evolving” and more complicated than in the past in terms of demonstrating a product’s major therapeutic...
USA – FDA offers guidance on observational studies as RWE
The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as...
USA – FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products
On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s...
USA – FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years...
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)....
