In 2002–03, the SARS virus infected 8,000 people in more than two dozen countries and killed almost 800. Infectious disease specialists created a specific check box list to identify viruses to watch out for pandemic potential in the future. Two are very important virus characteristics at the top of that specific check box list. One […]
Nasopharyngeal swabs are considered the gold standard to accurate test COVID19 infection. Unfortunately, these tests require specific supplies, some significant time for results, and place health care workers at risk of infection. Thus, clinicians and researchers have been looking for alternatives to nasopharyngeal swabs since the early days of the pandemic. Recently, it has been […]
Moderna published (https://medcitynews.com/2020/09/moderna-publishes-phase-iii-covid-19-vaccine-study-protocol-as-trial-enrolls-more-than-80-of-participants/?rf=1) that the Phase III Covid-19 vaccine study protocol enrolled 25,296 of its planned 30,000 participants which is more than 80% of participants. Of all enrolled subjects, 10,025 have received the full vaccine. This mRNA-1273 Moderna’s vaccine consists of two shots – one delivered on day 1, and a booster shot that participants […]
On August 24, PNAS – A very high risk of COVID 19 infection in primate species has been reported. Their analysis predicts that several critically endangered primate species are at very high risk of the virus, although the results need to be confirmed with further experiments or surveillance. An international team of scientists has assessed […]
Blood-based immunological changes that are linked to the disease and, in some cases, to symptom severity were published in Nature Medicine Source: (https://www.nature.com/articles/s41591-020-1038-6). For a disease with such diversity of symptoms and outcomes, and in patients of different ages and sexes with different underlying conditions, finding a common immune pattern of the immune response to […]
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A Priority Review designation does not alter the scientific/medical standard for approval or the quality of evidence necessary and it does not affect the length of the clinical trial period. Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. FDA drug review time includes two-tiered system […]
The IND requires very detailed product and development data such as information related to manufacturing, data from nonclinical studies, and previous clinical studies related to the IMP. IND also requires a comprehensive source of documentation including study reports. It follows the CTD structure developed by ICH and is mandatory to be submitted in the eCTD […]
We were pleased to be invited by Nancy C. Caralla of the C Diff Foundation to this important discussion on the Voice America Radio Network about how Microbiome functions and how its changes impact our health. Join us with our guest: Dr. Candida Fratazzi, Consulting Medical Director at Vedanta Biosciences, focused on pioneering rational design […]
Pediatric Rare diseases and Rare Pediatric Disease Designation FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified. Section 529 of the FD&C Act is intended to encourage development of new drug and biological products for the prevention and treatment of rare pediatric diseases. Section […]