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Clinical Research Solutions
What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
Regulatory Sciences
Last month, FDA published a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance was published with the intention of...
Clinical Research Solutions
On December 9, 2015, the FDA released a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely,...
Regulatory Sciences
In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft...
Clinical Research Solutions
In November 2013, the FDA introduced a proposed rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” Last month, the Agency announced the...
Clinical Research Solutions
Is your project schedule ready to pass the Project Management Institute’s (PMI) "litmus test"? Not sure? Well, the Project Management Team at ProPharma is here to lend a helping hand. Below are some...
Clinical Research Solutions
FDA’s Center for Drug Evaluation & Research (CDER) 2016 Priorities & Areas of Focus Front Burner Priorities: Negotiate PDUFA 6 agreements Negotiate GDUFA 2 agreements Negotiate a second BSUFA program...
Clinical Research Solutions
On Monday, December 14th, the director of FDA's Center for Drug Evaluation and Research (CDER), Janet Woodcock, M.D., spoke at the FDA/CMS Summit for Biopharma Executives where she announced the...
Clinical Research Solutions
FDA's Center for Drug Evaluation & Research (CDER) 2015 Priorities & Accomplishments Front Burner Priorities: GDUFA: meeting and exceeding performance goals; confident the division can reach steady...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...