The BBCR team will empower Sponsors with medical insight, ODA application experience, strategic clinical planning, and streamlined trial design.
Tagged: orphan drug designation
Orphan drug designation provides critical incentives for the ODA, including significant tax credits for qualified clinical testing. Learn more about Precision Medicines’ Impact on Orphan Drug Designation or contact BBCR today at (617) 401-2327.
August 14th, 2023 | orphan drug designationOrphan drug designation provides key incentives of the ODA, including significant tax credits for qualified clinical testing. The BBCR team will empower sponsors with medical insight, ODA application experience, strategic clinical plan, and streamlined trials design.
October 12th, 2022 | orphan drug designation
Developing drugs with substantial benefits in smaller, molecularly defined, pharmacologically relevant subpopulations of patients with the same clinically recognized disease is increasingly being viewed as a viable pathway for bringing drugs to market.
Breakthrough Therapy Designation and Orphan drugs
August 20th, 2020 | orphan drug designation
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 […]
Pediatric Rare diseases and Rare Pediatric Disease Designation – Boston Biotech Clinical Research
August 4th, 2020 | orphan drug designation
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 […]