Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. Click the button below to learn more about how we have helped companies with their clinical trial needs.
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 […]
The World Orphan Drug Congress USA will be a live virtual conference. BBCR’s Team invites you to send an email at info@nisse.serpcom.com/bbcr2. We hope to meet many of you that will attend the World Orphan Drug Congress. We are very much interested in learning about your programs to determine if BBCR’s expertise in Rare Diseases […]
Patients with mild COVID 19 infection, from a variety of age groups, were still experiencing major symptoms for months after COVID 19 disease is over. Read full article: https://jamanetwork.com/journals/jama/fullarticle/2768351 The Jama study was conducted in 143 COVID 19 patients. The mean age was 56.5 (SD, 14.6) years (range, 19-84 years), and 53 (37%) were women. […]
A transient neutralizing Ab (nAb) response is a feature shared by both COVID19 infection and the coronaviruses that cause common colds (https://www.medrxiv.org/content/10.1101/2020.07.09.20148429v1) Antibody (Ab) responses to SARS-CoV-2 can be detected in most infected individuals 10-15 days following the onset of COVID-19 symptoms. Seroconversion occurred in >95% of cases and neutralizing antibody (nAb) responses. All subjects, […]
SARS-CoV-2 outbreaks that cannot be explained by large droplets and contact with surfaces alone. Droplets from speech can float in air for eight minutes. A growing body of evidence suggests beyond any reasonable doubt that the virus spreads indoors through tiny aerosols—a finding that should be reflected in the WHO’s recommendations. Like the flu, COVID-19 […]
Scientists launched studies in search of genes that could explain why some people infected with SARS-CoV-2 get really sick, while others have only mild symptoms. We know that chronic health conditions—such as hypertension and diabetes can play a role, but there are also evidences that people’s genes can influence how their bodies react to other […]