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Clinical Research Solutions
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
Clinical Research Solutions
In November 2013, the FDA published a draft guidance entitled, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.” The reason for the draft guidance was to...
Clinical Research Solutions
On April 1, 2015, FDA held a public workshop entitled, “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” During the meeting, the Agency provided “updates on...
Clinical Research Solutions
In November 2015, the FDA released a draft guidance entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data.” The draft guidance was published for comment purposes only, and shared the...
Clinical Research Solutions
Robert M. Califf, MD, Deputy Commissioner for FDA Center of Medical Products and Tobacco & President Obama's Nominee for FDA Commissioner On Tuesday, January 12, the US Senate Committee on Health,...
Clinical Research Solutions
Over the past several years, outsourcing within the pharmaceutical supply chain has become common. The rise of the “virtual” pharmaceutical company has resulted in a complex supply chain, with the...
Clinical Research Solutions
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
Clinical Research Solutions
On Monday, January 4th, the FDA released two final orders which increased the regulation of surgical mesh used to repair pelvic organ prolapse (POP). The orders were developed in order to strengthen...
Clinical Research Solutions
Last week, the FDA announced plans to take a more aggressive approach to reporting medical device safety warnings to the public. The initial notification was delivered via an email announcement, and...
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...