Featured Issue Briefs
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
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
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
More Issue Briefs
| Date | Issue Briefs | Topic |
|---|---|---|
| Jul 2, 2009 |
Bill Summary - Counterfeit Drug Enforcement Act of 2009This issue brief is a summary of H.R. 2726 - The Counterfeit Drug Enforcement Act of 2009, also known as the Tim Fagan Law. More info |
Drug Safety, Medical Safety Policy |
| Jul 8, 2013 |
Letter from Pew and Premier to the OMB on Unique Device Identifier RuleThe 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. More info |
Drugs and Devices at the FDA |
| Jun 27, 2013 |
Letter from Pew: Release of the Unique Device Identifier Final RuleA 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 info |
Drugs and Devices at the FDA |
| Jun 18, 2013 |
Letter from Pew: Updates on the Unique Device Identifier SystemA letter from Josh Rising, director of Pew's Medical Device Initiative, about updates on the unique device identifier system. More info |
Drugs and Devices at the FDA |
| May 30, 2013 |
Letter from Pew to FDA on Postmarket Surveillance PlanFDA recently updated the national medical device postmarket surveillance plan – listing device identification and registries as the cornerstones for effective product monitoring. In this letter, medical devices director Josh Rising applauds the agency for making unique device identifiers and registries central to this plan. |
Drugs and Devices at the FDA |
| Apr 25, 2013 |
Letter From New Democrat Health Care Task Force to FDA on Unique Device Identification SystemThe three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database. More info |
Drugs and Devices at the FDA |
| Feb 5, 2013 |
Comments on the Health Information Technology Patient Safety Action and Surveillance PlanIn comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology, Consumers Union, the National Women's Health Network, the National Research Center for Women and Families, the Trust for America's Health, and The Pew Charitable Trusts urge the ONC to promote adoption of the unique device identification (UDI) system for medical devices to improve the safety of medical care. More info |
Drugs and Devices at the FDA |
| Jan 15, 2013 |
Comments on Stage 3 of the the Meaningful Use of Health Information TechnologyIn comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology and The Pew Charitable Trusts urge the ONC to incorporate medical device identifiers developed under the FDA’s unique device identification (UDI) system into both electronic health record (EHR) certification criteria and Stage 3 meaningful use (MU) objectives. More info |
Drugs and Devices at the FDA |
| Nov 21, 2012 |
Strengthening Our National System for Medical Device Postmarket SurveillanceThe Medical Device Initiative submitted comments to the U.S. Food and Drug Administration concerning the FDA's National Medical Device Postmarket Surveillance Plan, "Strengthening Our National System for Medical Device Postmarket Surveillance." More info |
Drugs and Devices at the FDA |
| Nov 8, 2012 |
Pew Comments to the FDA Regarding the Unique Device Identification SystemPew’s Medical Device Initiative, along with the American Heart Association and Trust for America’s Health, submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule for a unique device identification (UDI) system for medical devices. Once implemented by the FDA and utilized by healthcare providers, the UDI system will be the cornerstone for significant improvements in postmarketing surveillance of medical devices. More info |
Drugs and Devices at the FDA |
| Jun 1, 2010 |
Toxic Chemicals and Reproductive HealthOver the past few decades, the reproductive health of Americans appears to have declined. Diseases, disorders and conditions that affect the development and functioning of the male and female reproductive systems—including fertility problems, miscarriages, pre-term births, low birthweights and certain birth defects—have risen. In addition, incidence rates of testicular cancer have increased, and breast and prostate cancers remain among the most common forms of cancer in the U.S. More info |
Environmental Risk |
| Apr 1, 2010 |
Toxic Chemicals and a Child's Brain DevelopmentToday, one in six children in the United States has a developmental or learning disability. Some experts say many of these may be due in part to early exposures to toxic chemicals. The number of children diagnosed with these disabilities has increased dramatically over the past four decades. More info |
Environmental Risk |
| Aug 3, 2012 |
Pew Comments on Draft Guidance for Industry Regarding Nanotechnology in FoodThe Food Additives Project of the Pew Health Group strongly agrees with the FDA's draft decision to deny "generally recognized as safe" (GRAS) status to nanoengineered chemicals and review them as food additives. However, they list their concerns with certain aspects of the document and question the agency's claim that it has not reviewed GRAS notifications sanctioning the use of nanoengineered chemicals. More info |
Food Additives |
| Jul 27, 2012 |
Review of the Scientific Basis for Safety Decisions on Hazards of Substances Added to FoodIn April 2011 Pew Health Group convened a workshop bringing together more than 80 experts from government, industry, academia and public interest organizations to examine the principles underlying the development and use of scientific evidence to identify and characterize chemical hazards. Based on the workshop discussions, Pew made several important observations. More info |
Food Additives |
| Mar 1, 2012 |
Clostridium difficile: Rapidly Emerging Bacteria that Flourish in the Face of AntibioticsNearly 45,000 Americans died from CDI between 1999 and 2009. More info |
Food Hazards |
