Documentation Drug Development Vaccines 
pharmaphorum
APRIL 8, 2021
COVID-19 has been a trial-by-fire showing just how quickly drugs and vaccines can be developed under the right circumstances – but there is much to do to ensure this progress is not lost, said speakers at WIRED Health 2021, including the CEOs of BioNTech and BenevolentAI. .
pharmaphorum
NOVEMBER 10, 2021
After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony.
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pharmaphorum
OCTOBER 28, 2020
Data defines modern therapeutics, but this is almost uniquely confined to the clinical trial stages of drug development. In the UK, for example, more than half the public expressed an unwillingness to take a vaccine unless it had been tested for at least a year.
pharmaphorum
JANUARY 27, 2023
Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said. But who is benefitting?
FDA Law Blog: Biosimilars
SEPTEMBER 10, 2023
Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.
European Pharmaceutical Review
NOVEMBER 16, 2022
As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment.
Viseven
DECEMBER 4, 2024
One of the most tragic was the thalidomide disaster, in which pregnant women prescribed the drug to treat morning sickness suffered severe birth defects. This made drug developers realize that flaws in the manufacturing process could go unnoticed. By the late 1970s, the concept of process validation was introduced.
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