FDA
The Food and Drug Administration (FDA) has developed a guidance document dedicated to the benefit-risk factors to be considered when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics. The document is...
North America
The FDA finalized guidance regarding the use of placebos and blinding during randomized cancer trials. The guidance finalizes a draft made in 2018 and clarifies scenarios where placebo designs and blindings should be justified. WHAT IS A PLACEBO? A placebo is an inert...
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