FDA Designates Empirically Based Bayesian Emax Models for Dose Finding as ‘Fit-For-Purpose’: On August 5, 2022, the U.S. Food and Drug Administration (FDA) designated ‘Empirically Based Bayesian Emax...
FDA Issues FY2021 Report on the State of Pharmaceutical Quality: The Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research has published the fiscal year 2021...
August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on...
FDA Publishes Responses to Good Clinical Practice Inquiries: FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations....
Draft Guidance for Industry and Food and Drug Administration Staff AUGUST 2022 FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care...
GUIDANCE DOCUMENT - Guidance for Industry and FDA Staff AUGUST 2022 In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD)...
This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and...
August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...
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...