RegDesk Regulatory Roundup

India Deliberating the Right to Try India

India Deliberating the Right to Try

Experts and pharmaceutical companies in India may grant terminally ill patients access to drugs that have not yet been cleared through clinical trials. The new policy would serve as a last resort for patients who are left with no available approved treatments. A draft...

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FDA’s Guidance on Placebos North America

FDA’s Guidance on Placebos

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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