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Clinical Research Solutions
On February 4, Robert Califf, MD, FDA’s Deputy Commissioner for Medical Products and Tobacco, released a new plan to reassess the Agency’s approach to opioid regulation. The plan includes a number of...
Clinical Research Solutions
On February 1, 2016, the Biosimilars Forum, a nonprofit organization dedicated to increasing biosimilar access in the US, announced the launch of “Partnership for Biosimilar Education and Access,” a...
Clinical Research Solutions
On Wednesday, FDA released a draft guidance entitled “List of Highest Priority Devices for Human Factors Review.” The draft guidance was published by FDA’s Center for Devices and Radiological Health...
Clinical Research Solutions
On January 28, 2016, the FDA and Commonwealth Informatics entered into a two-year agreement where they will work together to develop a platform to help the Agency assess drug safety data. The...
Clinical Research Solutions
On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...
Clinical Research Solutions
On January 28, 2016, an FDA and NIH Joint Leadership Council published its first official glossary of terms and definitions, which “clarifies important definitions and describes some of the...
Clinical Research Solutions
On June 11, 2010, the FDA published its draft guidance entitled “Bioequivalence Recommendations for Specific Products.” This draft guidance “explained the process that would be used to make...
Clinical Research Solutions
On Tuesday, January 12, 2016, Senator Tammy Baldwin (D – WI) introduced the “Advancing Standards in Regenerative Medicine Act,” a bill supporting the development of regulatory science and the...
Clinical Research Solutions
On November 25, 2015, Amgen Inc. submitted a Biologics License Application (BLA) for ABP 501, the company’s biosimilar candidate to Humira® (adalimumab). Earlier this week, Amgen announced that its...
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...