FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. August 2022 This final guidance is intended to help applicants (or “you”) design and...
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...
Today, the U.S. Food and Drug Administration (FDA) issued a final rule: Establishing Over-the-Counter Hearing Aids to improve access to safe, effective, and affordable hearing aids for millions of...
Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA...
Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
The exact product development process for medical devices differs from region to region, with different regulatory expectations that need to be met in the EU, USA, UK and other regions. These precise...
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...