Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
On Tuesday, November 20th, FDA announced the establishment of a public docket to solicit comments and feedback on a proposed framework regarding the regulation of prescription drug-use-related...
On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations,...
On Friday, November 2nd, FDA announced its approval of Dsuvia™, a highly potent synthetic opioid manufactured by AcelRx Pharmaceuticals, Inc. The drug is a sublingual (under the tongue) formulation...
On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices. When signed, the Cures Act increased FDA’s...
Last week, the FDA published two statements regarding its involvement in efforts to combat the opioid epidemic afflicting the U.S. FDA Cracks Down on Websites Selling Illegal Opioids On Tuesday,...
On Wednesday, October 24th, FDA approved Xofluza (baloxavir marboxil), a single-dose oral flu medication. The product is indicated for the treatment of acute uncomplicated influenza (flu) in patients...
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
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...
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...
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...
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...
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...