2011 Documentation Drug Development 
European Pharmaceutical Review
SEPTEMBER 22, 2022
Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). These assessments often need to involve comparisons against multiple alternative therapies that would be impractical in the context of a clinical drug development. Regulatory and payer guidance. Patel et al.
pharmaphorum
APRIL 27, 2021
Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.
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European Pharmaceutical Review
JULY 4, 2024
The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. The worldwide trend of using botanical drugs and strategies for developing global drugs.
FDA Law Blog: Biosimilars
FEBRUARY 28, 2024
This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA).
PharmaTech
JUNE 23, 2025
Discussion topics Part two of this series ( click here for part one ) addresses numeric calculations for types of bulk drugs. It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties.
European Pharmaceutical Review
FEBRUARY 1, 2024
What are the top three trends impacting the cardiovascular drug development space today? Even though patients are on these existing therapies that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death.
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