Aug 21, 2020 | News, Regulatory
Health Canada has adopted a nonclinical safety testing guidance to help develop medication in pediatrics. This guidance called GuidanceS11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines has been developed by the ICH and is slated to be... 
Aug 19, 2020 | News, Regulatory
Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotnib, a treatment for rheumatoid arthritis, which the FDA rejected due to safety concerns, particular in the 200mg dose. “We are disappointed in this outcome and will... 
Aug 17, 2020 | News, Regulatory
The US Food and Drug Administration (FDA) proposed reclassifying non-invasive bone grown stimulators from Class III to Class II, reducing the regulatory burdens and allowing the devices to be marketed with 501(k) clearance rather than requiring premarket... 
Aug 14, 2020 | News, Regulatory
The Food and Drug Administration (FDA) asked for rare disease stakeholders, including individuals and families affected by rare disease(s), pharmaceutical companies, trade associations, and other federal agencies and regulators, to weigh in on a proposed clinical... 
Aug 12, 2020 | News, Regulatory
Vladimir Putin announced on yesterday (8/11) of Russia’s approval for COVID-19 vaccine, “Sputnik V”. The approval comes before the vaccine has completed its final stages in the clinical trials, causing worry from both inside and outside the country. The first round of... 
Aug 10, 2020 | News, Regulatory
The US Federal Drug Administration (FDA) with the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) has provided guidance today (8/10) for drug-drug interaction studies of therapeutic proteins. The guidance...
