BILTHOVEN, Netherlands & MARLBOROUGH, Mass.—Factory-CRO Group, a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), and Boston Biomedical Associates(BBA) a premier full-service Medical Device/Biotechnology CRO and Consultancy based in the United States announce…
FDA Proposes Informed Consent Waivers for Some Clinical Trials. Would this be possible anytime in India?
Researchers in low-risk clinical trials could experiment on patients without obtaining informed consent if they meet at least four conditions, the FDA proposed last week in a new rulemaking notice. The agency will grant waivers if researchers can prove: A…
Boost for MNCs as price cap removed for first 5 years on innovative drugs
New-Delhi: The government on Thursday exempted innovative medicines developed by foreign companies from price control for five years, giving Indian patients access to drugs that are currently only available abroad. These include orphan drugs that are used for treating rare medical…
FDA-cleared, wearable blood pressure device hits market
Dive Brief: A Chicago area health devices company said Thursday it would begin pre-sales of an FDA-cleared blood pressure monitor that can be worn on the wrist, the latest example of a medical device that has been adapted to smart…
