by Maya Caldwell | Aug 1, 2018
After the US Food and Drug Administration (FDA) released its 11-part biosimilar action plan, FDA has now announced that it will hold a public hearing to gather input “on how it can facilitate the development of biosimilars and ensure they enter the market in a timely...
by Maya Caldwell | Aug 1, 2018
On February 21, 2018 the US Food and Drug Administration (FDA) published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices. The new rule states that sponsors and applicants conducting clinical investigations outside of...
by Maya Caldwell | Jul 19, 2018
On July 11, 2018 the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) offered 6 new draft guidance documents on human gene therapies. The documents offer a look at what it expects from an industry that is becoming very popular,...
by Maya Caldwell | Jul 18, 2018
On July 12, 2018, the US Food and Drug Administration (FDA) announced the creation of a new drug shortages task force, led by Keagan Lenihan as well as leaders from the Centers for Medicare and Medicaid Services (CMS). Kaegan is the FDA’s associate commissioner for...
by Maya Caldwell | Jul 13, 2018
FDA’s Center for Devices Radiological Health (CDRH) intends to expand on the existing Abbreviated 510(k) program that was described in draft guidance in April. However, many companies such as Medical Imaging & Technology Alliance (MITA), AdvaMed, and others voiced...
