Featured Issue Briefs

The Battle on the Home Front: Jonathan Gadsden's Story

The Battle on the Home Front: Jonathan Gadsden's Story

Marine Lance Corporal's story reflects the growing need for new antibiotics that can treat dangerous diseases, against which most drugs are useless. Read More

Facilitating Medical Device Innovation: De Novo Reform

Facilitating Medical Device Innovation: De Novo Reform

The de novo process -- which requests lower-risk reclassification of medical devices and entry into the marketplace -- as it exists now is not achieving its purpose and has instead added unnecessary and time-consuming requirements. Read More

Food Products Recalled by FDA

Food Products Recalled by FDA

Since President Obama signed the FDA Food Safety Modernization Act into law, at least 149 FDA-regulated food products have been recalled due to potential pathogenic contamination. Read More

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Jun 18, 2013

Letter from Pew: Updates on the Unique Device Identifier System

A letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system.

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Drugs and Devices at the FDA

Jun 26, 2013

Drug Development for Limited Populations: A New Proposed Pathway

The lack of new antibiotics and the rise in drug resistance have rendered some serious and life-threatening infections untreatable, and the health care community is searching for ways to bring innovative new drugs to patients whose treatment options are limited or nonexistent. More

Antibiotic Innovation

Jun 27, 2013

Letter from Pew: Release of the Unique Device Identifier Final Rule

A letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system. More

Drugs and Devices at the FDA

Jul 8, 2013

Letter from Pew and Premier to the OMB on Unique Device Identifier Rule

The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.

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Drugs and Devices at the FDA