FDA Related News

Advancing Use of Patient-Reported Outcomes

Researchers suggest priorities needed to increase the use of patient-reported outcomes as data in real-world evidence.

Human Drugs

FDA OKs Combo Drugs for Kidney Cancer

FDA approves an EMD Serono and Pfizer NDA for Bavencio (avelumab) in combination with Pfizers Inlyta (axitinib) for the first-line treatment of patien...

Human Drugs

Pfizer sNDA Approved for Pediatric-use Fragmin

FDA approves a Pfizer sNDA for Fragmin (dalteparin sodium) subcutaneous injection to reduce the recurrence of symptomatic venous thromboembolism in pe...

Medical Devices

Ethicon Recalls Endo-Surgery Intraluminal Staplers

Ethicon recalls its Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler wi...

Human Drugs

Drug Development Landscape Evolving

Iqvia Institute identifies and analyzes trends in drug research and development in the next five years.

Human Drugs

FDA Part of Generic Drug Bioinformatics Research

University of Florida and Office of Generic Drugs researchers are developing a bioinformatics approach to evaluating bioinequivalence reports on gener...

Medical Devices

Masimo Radius PPG Tetherless Sensor Cleared

FDA clears a Masimo 510(k) for the Radius PPG, a tetherless sensor associated with the Masimo SET patient monitor.

Human Drugs

FDA Cant Regulate Execution Drugs: DoJ Opinion

The Justice Department Office of Legal Counsel says FDA lacks jurisdiction to regulate articles intended for use in carrying out capital punishment by...

Medical Devices

AdvaMed Backs 510(k) Pathway

AdvaMed voices approval for the current 510(k) program and for some efforts to improve it.

Human Drugs

Pew Trusts Sees Need for OTC Monograph Reform

The Pew Charitable Trusts lays out reasons why Congress should revise the system to update over-the-counter product monographs.