In December of 2018, the FDA published their Framework for FDA’s Real-World Evidence Program, which outlines the allowed usage of Real World Data (RWD) and Real World Evidence (RWE) in FDA submissions. The sources of RWD and the application of RWE The rationale for using Real-World Data (RWD) is to help support the approval of […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-01-21 11:31:372019-01-21 11:31:37FDA Publishes Framework for Real-World Evidence Program
In December 2018 the FDA released new guidelines for clinical trials of cancer drugs and biologics. Such endpoints serve different purposes at different points in time during the trial. During early trials the focus is on efficacy and safety. Later on, trials select endpoints for clinical benefits like improved survival and symptom relief. For […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-01-17 18:39:372022-11-11 18:30:12New Breakthroughs Create New Cancer Research Endpoints
Master Protocol Designs Mean Increased Competition The FDA has updated and modernized its clinical trial designs. That means a lower cost, more efficient process leading to a more competitive market and lower prices. Not only will this make it easier to bring new treatments to market, it will also increase the amount of similar treatments. […]
None of your partners are trying to make your late stage approvals process difficult. But they might be doing it anyway. It’s not uncommon for the root of a problem to lie not with your organization, but with a partner CRO. Here are some of the most common ways partner organizations can complicate your FDA […]
In a sense, FDA regulations are a game of political football. The goal posts are always moving. As new administrations come in, so do new administrators. The current year is no different, with a number of areas shaping up to be contentious points with regard to FDA approvals.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2018-09-10 09:48:372023-07-21 18:50:14Contentious FDA Controversies in 2018
FDA Publishes Framework for Real-World Evidence Program
in Real World DataIn December of 2018, the FDA published their Framework for FDA’s Real-World Evidence Program, which outlines the allowed usage of Real World Data (RWD) and Real World Evidence (RWE) in FDA submissions. The sources of RWD and the application of RWE The rationale for using Real-World Data (RWD) is to help support the approval of […]
New Breakthroughs Create New Cancer Research Endpoints
in FDA Approval, Phase-3 BioIn December 2018 the FDA released new guidelines for clinical trials of cancer drugs and biologics. Such endpoints serve different purposes at different points in time during the trial. During early trials the focus is on efficacy and safety. Later on, trials select endpoints for clinical benefits like improved survival and symptom relief. For […]
FDA Modernizes Clinical Trial Designs
in Getting FDA ApprovalMaster Protocol Designs Mean Increased Competition The FDA has updated and modernized its clinical trial designs. That means a lower cost, more efficient process leading to a more competitive market and lower prices. Not only will this make it easier to bring new treatments to market, it will also increase the amount of similar treatments. […]
How Your Partners Might Fail to Properly Understand Regulations
in Getting FDA ApprovalNone of your partners are trying to make your late stage approvals process difficult. But they might be doing it anyway. It’s not uncommon for the root of a problem to lie not with your organization, but with a partner CRO. Here are some of the most common ways partner organizations can complicate your FDA […]
Contentious FDA Controversies in 2018
in Getting FDA ApprovalIn a sense, FDA regulations are a game of political football. The goal posts are always moving. As new administrations come in, so do new administrators. The current year is no different, with a number of areas shaping up to be contentious points with regard to FDA approvals.