Africa
Karen M, one of our Switzerland-based consultants, recently shared her insights into emerging markets of medical device with us. Here are Karen’s five tips to consider before sending your product to a new or developing market: Understand existing regulations...
Europe
Over the last two decades, biologics have revolutionized the treatment of illnesses such as diabetes, cancer, rheumatoid arthritis and hepatitis. However, many prominent biologics are about to have their patents expire in the U.S., making way for biosimilars....
North America
What is the FDA new policies “Refuse to Accept” Policy/Acceptance Review Process? On December 31st 2012, the U.S. FDA released two final guidance documents outlining new acceptance review processes that apply to 510(k) Premarket notifications and...
North America
What is the Open FDA Initiative? In June 2014, the U.S. FDA launched the “open FDA” a technology-driven initiative to make government information easily accessible to the public. The initiative was initially an order from the White House to implement a new...
North America
The Food and Drug Administration has announced that it will be increasing the fee rates and payment procedures for medical device user fees by 4.2%. What is the Medical Device User Fee? Originally established in 2002 by the Medical Device User Fee and Modernization...
North America
The U.S. Mobile Health industry is growing at a rapid rate due to numerous technological advancements. Our chart compares the industry’s annual growth rate to that of the country’s gross domestic product (GDP) over the same 10-year period. IBISWorld notes...
