Pearls of Wisdom
Final Rule on Data Acceptance from Clinical Investigations for Medical Devices
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...
New Draft Guidance on Gene Therapy
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11, 2018 the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) offered 6 new draft guidance documents on human gene therapies.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...
FDA announces new Drug Shortages Task Force
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...
Opportunity costs and electronic submissions to FDA
As of May 5, 2018, all submissions to FDA must go through the Agency’s electronic gateway. There are three parts to processing electronic submissions with FDA. They are: Transforming the documents into pdf format. Placing the individual PDFs into the...
Abbreviated 510(K) Option proposed by CDRH Raises Questions
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Devices Radiological Health (CDRH) intends to expand on the existing Abbreviated 510(k) program that was described in draft guidance in April.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...