The US FDA is currently reviewing its pharmaceutical manufacturing Guidance, after receiving feedback from industry trade groups. What will the new Guidance mean for pharma companies, as well as ...
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FDA protocol deviation guidance could go furtherThe US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...
Current laws and regulations are not enough to protect Americans from the risks of compounded versions of popular weight loss ...
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
It is generally well appreciated that the pharmaceutical industry has entered a period ... company-reported historical revenues, the FDA Orange Book, and SEC filings to predict the revenues ...
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