Jan 26, 2021 | News, Regulatory
Yesterday (1/25), Australia’s Therapeutic Good Administration (TGA) authorized Pfizer and BioNTech’s COVID-19 vaccine. The provisional approval is the first for COVID-19 vaccines in Australia’s market for individuals 16 years and older and is expected to be... 
Jan 25, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune... 
Jan 22, 2021 | News, Regulatory
Curelator, a digital health company based in Cambridge, MA, released its findings for the largest international study that focused on the relationship between stress and migraines in the January issue of Headache, The Journal of Head and Face Pain in collaboration... 
Jan 21, 2021 | News, Regulatory
Yesterday (1/20), Novavax received provisional determination from Australia’s Therapeutic Goods Administration for its COVID-19 vaccine, marking the first steps in gaining provisional approval. Australia’s provisional approval pathway allows for drug therapies (or... 
Jan 21, 2021 | e-Labeling, EMA, Health, Language Service Provider, Medical Translation, Regulatory
On May 26th 2021, the European Union’s Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC) will be replaced and fully covered by the Medical Device Regulation (MDR). Since the original medical device directive’s... 
Jan 20, 2021 | News, Regulatory
Seneca Biopharma announced today (1/20) its preliminary top-line results for their Phase 2 ischemic stroke study. The trial, which took place in Beijing, China, focused on evaluating the relative safety of NSI-566, a neural stem cell therapy, in patients afflicted... 
Jan 19, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as... 
Jan 15, 2021 | News, Regulatory
The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use... 
Jan 14, 2021 | News, Regulatory
Medtronic announced today (1/14) the launch of its clinical trial enrollment of the innovative Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD). The novel trial, which will take place across 12 research study sites in the US, Europe... 
Jan 13, 2021 | News, Regulatory
The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
