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...
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...
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...
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...
For businesses in the life sciences looking to globalize their product or service, accurate and high-quality regulatory translation is essential for market access and success. Companies creating innovative, lifesaving or life enhancing drug therapies and devices,...
Linguistic validation is a technique of reviewing and validating the accuracy, reliability, and equivalency for measurements of patient-reported outcomes (PROs). These outcomes, directly reported by patients, help determine the usefulness and efficacy of various...
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...
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...
COVID-19 has forced most of the world to work remotely, causing a major disruption in clinical research and the drug development process. As a result, the need for centralized and advanced patient engagement technology to better healthcare for all parties involved,...
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for Covid. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send almost the entirety...
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