Pre-Market Testing Guidance Pilot Program Released by FDA
The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
FDA Grants EUA for Point-of-Care COVID-19 Antibody Test
Amidst the COVID-19 public health crisis, many companies have worked tirelessly to perfect testing technology. Assure Tech, a Chinese company based in Hangzhao, has prevailed with an antibody test with emergency use authorization. This is the first time that the FDA...
Paraxel Announces Resource for EU Clinical Trials Information System Regulation
With the incoming implementation of the EU Clinical Trial Regulation 536/2014 in December 2021, Parexel, an end-to-end innovative therapeutics solutions provider, has announced the launch of their Regulatory Submissions Hub Service for their life science and...
Resurgence of COVID-19 Cases in European Cities Causes New Restrictions
In the most recent report from the UK this past week, cases of COVID-19 have doubled to about 6,000 per day. While infections have been on a slow and steady increase in Europe over the last two months, especially in Spain and France, governmental bodies are...
Orphazyme Receives Priority Review by FDA for Treatment of Niemann-Pick Disease Type C
Orphazyme, a biotech company based in Denmark, announced today (9/16) that the FDA has accepted its New Drug Application (NDA) for treatment of Niemann-Pick disease Type C. The genetic disease is both rare as well as fatal, with no currently approved...
NICE Reverses Disapproval of AstraZeneca’s Lung Cancer Therapy Tagrisso
The National Institute for Health and Care Excellence (NICE) originally rejected global biopharmaceutical company AstraZeneca’s lung cancer therapy Tagrisso (Osimertinib), but has since decided to reverse its initial decision. NICE initially did not recommend Tagrisso...
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