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 ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
GlobalData on MSN

CSA Medical submits application to FDA for RejuvenAir System

The system aims to address underlying chronic cough and issues with mucus production and clearance in chronic bronchitis.

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 ...
CounterPunch

The FDA Fails to Protect Americans from the Medical Device Industry

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

Alpha Tau Submits First Pre-Market Approval Module to the FDA for Alpha DaRT(R) for the Treatment of Recurrent Cutaneous Squamous Cell Carcinoma (cSCC)

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 ...