Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Fast-tracked drug approvals pose safety risks, study shows

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT(R) for the ...

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The ...
PBS

One medical device is raising questions about FDA’s approval process

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...
Medscape

FDA Tightens Approval Process for Radiotherapy Devices

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
FiercePharma

FDA misses another approval decision target date, this time for GSK's Nucala in COPD

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod ...