The Premier Consulting Blog
NOVEMBER 20, 2023
Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.
Vial
FEBRUARY 29, 2024
Understanding the Numbers: How Many Clinical Trials Utilize CROs? Every year, thousands of clinical trials take place, and a large percentage of these are overseen by CROs. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.
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The Pharma Data
JANUARY 25, 2021
This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. If the initial purchasers exercise their option to purchase additional notes in full, the Company expects to use approximately $8.0
Agency IQ
AUGUST 18, 2023
Expert panels have two main tasks under the MDR and IVDR, which is to provide opinions and view as part of the clinical and performance evaluation consultation procedures (MDR Article 54 / IVDR Article 48). The second is ad hoc advice on clinical development plans and clinical investigation proposals.
Drug Target Review
MARCH 20, 2025
This potential breakthrough could transform both drug discovery and clinical treatment strategies, with the possibility of enhancing patient safety and improving outcomes in thrombotic conditions like atrial fibrillation. These studies, anticipated to complete in 2027, could open doors for abelacimab’s approval in this indication.
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