Regulatory Focus Features are a RAPS member benefit. Please log in with your RAPS member account to view the full article content. Not a RAPS member? Join today.
The increasing demand from government agencies, insurers and patients to reduce the steep cost of blockbuster biopharmaceutical products has created considerable opportunities in the global biosimilar market. This article reviews the various regional regulatory processes in effect to date and highlights the need for harmonization.
The China Food and Drug Administration (CFDA) has been actively expanding and updating its regulatory process for medical devices, including its 2013 Medical Device Supervision and Regulation.
There are many strands to consider when looking to the future in regulatory affairs, including regulations, global harmonization efforts, emerging public healthcare challenges and the capital markets.
This article provides an overview of Muscular Dystrophy (MD) and examines some of the complex features that make treatments for this group of diseases elusive. It provides an overview of the budding regulatory landscape for the treatment of MD in the EU and, finally, argues for more-detailed FDA guidance for each type of MD.
All Regulatory Focus Content
Regulatory Focus News
Regulatory Focus Features
Regulatory Focus Departments
Regulatory Focus is for regulatory professionals written by regulatory professionals.
The publication takes a look at the important topics facing regulatory professionals in a changing global healthcare landscape. From topics ranging from research and development to labeling and marketing, the articles try to analyze, inform, and educate readers about the issues at the forefront of the industry.
Rated as the number one benefit by the members of RAPS, Regulatory Focus strives to provide the best and most current information to regulatory professionals so they can succeed and advance at every stage in their careers.
For questions or comments on our content or to find out more about Regulatory Focus, please visit our About RF page.