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
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
by Priya Bhutani, CEO RegDesk – Summary Technical Document (STED) is the proposed harmonized format used for regulatory submissions by the Global Harmonization Task Force (GHTF). Albeit STED is in its pilot phase, it has the potential to standardize format for...
North America
Any manufacturer who wants to legally market their medical device in the US intended for human use has to get FDA approval. Any class I, II, or III devices, which is not exempt and does not require premarket approval must fulfill the requirements of a 510(k) of the...
North America
By Priya Bhutani — Obtaining market approval for a medical device from the US FDA seems arduous and frightening and most manufacturers do not know where to even begin. Medical devices are subject to general controls of the Federal Food Drug & Cosmetic...
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