RegDesk Regulatory Roundup

FDA Guidance on General Device Labeling FDA

FDA Guidance on General Device Labeling

The Food and Drug Administration (FDA or the Agency), the country’s regulating authority in the sphere of healthcare products, has developed detailed guidelines dedicated to labeling requirements for various types of medical devices. The present article supplements...

Read More

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...

Read More