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 ...
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...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 ...
Top of the morning to you, and a fine one it is, although we concede this may depend on your tolerance for frigid temperatures. Nonetheless, blue skies and a shiny sun are enveloping the Pharmalot ...
Pharma and Biopharma is a trillion-dollar industry providing ample career opportunities ... the fundamentals of assessing drug quality, and the basics of pharmaceutical regulations. This ACS Webinar ...
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 ...
Under FDA’s own guidelines, factories that haven’t been inspected ... by cutting quality,” said David Ridley of Duke University, who studies the pharmaceutical industry. “If they’re not inspected, ...