You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
In a landmark move insulin, along with other biologic drugs transitioned to the biologics regulatory pathway as of March 23rd. This transition is groundbreaking for millions of Americans as incidence of diabetes increases and accessibility to affordable insulin has become a matter of life and death.
Last week, the FDA and Federal Trade Commission (FTC) released a joint statement promoting collaboration to improve the marketplace for biological products, highlighting the necessity of incorporating biosimilars and interchangeable products and deterring anti-competitive behavior. Biological products are defined by FDA as “a diverse category of products…may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs.”
Topics: FDA, Federal Trade Commission, Biosimilars, Biologics