On Friday, October 29, 2021, the EMA published a statement providing marketing authorization holders (MAHs) recommended submission dates for 2021 variations in order to meet the regulatory deadlines....
On Wednesday, October 27th, FDA revoked Life Technologies Corporation’s Emergency Use Authorization (EUA) for its TaqPath COVID-19 MS2 Combo Kit 2.0. Background On August 2, 2021, FDA issued an EUA...
On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and...
It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be...
On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine phosphate tablets and hydroxychloroquine sulfate tablets, two drugs being investigated as potential...
On Wednesday, April 1, 2020, FDA issued a statement asking all companies to stop selling all forms of Zantac (ranitidine). Background On Friday, September 13, 2019, the FDA announced that “some...
On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications. In the report, GAO comments on the number of products approved on the first review...
Over-the-counter (OTC) drugs are defined by the FDA as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Currently, there are more...
On, Tuesday, June 11th, 2019, the FDA issued a final guidance document entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” The guidance was published less than...
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...