North America The FDA has finalized a guidance about citizen petitions against the approval of drugs, which delays the application process, and what they look for in petition submissions as well as why submissions might be denied. This comes after the abundant number of false...
India 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...
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...
Asia In April, China was hit by a vaccine scandal that has since resulted in a shortage of supply. Thousands of vaccine doses for children and adults were found to be improperly stored or expired. The vaccines were illegally sold for millions of dollars on the black...
Asia The China Food and Drug Administration (CFDA) has been changing how medical devices are regulated by expanding and updating their laws. They have released multiple draft documents which elaborate on the caliber of medical device clinical trials and devices that may be...
