Jun 9, 2021 | News, Regulatory
A new pneumococcal 20-valent conjugate vaccine by Pfizer, PREVNAR 20™, has been approved for adults by the FDA in efforts to strengthen the prevention of disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. The authorized vaccine not...
Apr 15, 2021 | Clinical Trials, Health, Healthcare
Patient centricity and patient diversity are two trends that have taken the life science sector by storm. Simply put, patient centricity is defined as “designing a treatment, clinical trial, or other health solution centered around the patient”. Patient diversity, on...
Feb 18, 2021 | Clinical Trials, e-Learning, Health, Pharmaceuticals, Regulatory
There is no doubt that clinical trials are vitally important in the drug development process. As an increasing number of clinical trials are conducted overseas, sometimes with multiple ongoing studies at once, having in-depth knowledge...
Feb 3, 2021 | Clinical Trials, FDA, News, Regulatory
The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action...
Dec 31, 2020 | News, Regulatory
According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK’s approval yesterday (12/30). Questions...
