This guide walks US-based clinical supply professionals through the EU GMP Annex 13 labeling requirements. Read More
Through a combination of new legislation, regulations, and enforcement policies, a new regulatory framework is coming for OTC drugs. Read More
What does the word “feasibility” mean to you? It may seem like a simple question, but I have found that “feasibility” has many interpretations within the clinical research industry. When we work with Read More
The requirement that new drugs show effectiveness is based on a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. This law requires substantial evidence of effectiveness and specifies that t Read More
When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, pla Read More
The term patient centricity is fraught with uncertainty for many. This term carries the nuances of widely varying practical application methods as well as theoretical disagreements from stakeholders Read More
Our global Life Sciences and Health Care team reports on current and evolving trends that are shaping the future of the industry. Read More
As of May 2018, U.S. sponsors of clinical studies conducted in the EU must be in compliance with EU's new General Data Protection Regulation or risk possibility of fines. Read More
The Department of Health and Human Services has proposed a one-year delay in implementation of the revisions to the Common Rule. Read More
Last week, the Senate pushed forward a tax reform proposal that would have taxed stock options as employees earned the right to receive them, rather than when those options are exercised. Read More