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 |
|---|---|---|
| May 31, 2012 |
Unmet Medical Need in Infectious DiseasesIntroduced more than 75 years ago, antibiotics have profoundly transformed health care. Thanks to these drugs and to advances in vaccines and infection control, many formerly devastating bacterial illnesses can be cured or contained. More info |
Antibiotic Innovation |
| Jun 22, 2012 |
Improving Medical Device Safety Through Better SurveillanceIn 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues. More info |
Medical Safety |
| Jun 22, 2012 |
Facilitating Medical Device Innovation: De Novo ReformThe de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements. More info |
Medical Safety |
| Jul 16, 2012 |
Food Animal Production and Antibiotic ResistanceAntibiotics are one of the most important tools in modern medicine. These drugs can mean the difference between life and death when humans contract a bacterial infection—from staph to salmonella to bacterial pneumonia. But overuse and misuse of these drugs are making bacteria more quickly resistant to essential antibiotics. More info |
Antibiotics in Food Animal Production |
| Jul 17, 2012 |
Obama needs to release draft food safety rules, say victims and advocacy groupsThe U.S. Centers for Disease Control and Prevention estimate that one in six Americans (48 million people) suffer from a foodborne illness each year, resulting in 128,000 hospitalizations and 3,000 deaths. Americans will continue to get sick and even die from foodborne disease as your Administration continues to hold up the food safety rules. In fact, the U.S Food and Drug Administration (FDA) essentially ensured such an outcome last week in a letter to food industry representatives. In it, the FDA said that until final rules are issued, the agency would not enforce the FSMA requirements that food processors adopt prevention-based protections, and that importers assure the safety of the food products they send to the United States. More info |
School Food, Food Hazards |
| Jul 17, 2012 |
Food Products Recalled By FDASince 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. A recall is needed when a failure in the food safety program in a food facility results in contaminated food products being shipped to supermarkets and other retail and wholesale outlets. A recall is the last line of defense that protects consumers from getting sick. More info |
Food Safety |
| Jul 20, 2012 |
58 Health and Consumer Groups Tell FDA to Close Loopholes in Antibiotic GuidelinesOver 50 health and consumer groups plead to the U.S. Food and Drug Administration that the federal government accelerate and expand actions to curtail the overuse and misuse of antibiotics in food animal production. Despite overwhelming scientific evidence that these practices threaten human health, the routine administration of antibiotics in industrial meat and poultry operations continues unabated, putting the health of all Americans at risk for dangerous antibiotic-resistant infections. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Hospitals Seek Stronger Guidelines for Antibiotic Use in Food AnimalsSeveral hospitals and medical centers across the United States joined forces in a letter to the U.S. Food and Drug Administration to accelerate and expand actions to curtail the overuse and misuse of antibiotics in food animal production. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
359 Health Professionals Ask FDA to Better Protect AntibioticsIn this letter to the U.S. Food and Drug Administration, 359 health professionals requested that the federal government accelerate and expand actions to curtail the overuse and misuse of antibiotics in food animal production. More info |
Antibiotics in Food Animal Production |
| Jul 20, 2012 |
Businesses to FDA: End Overuse of Antibiotics in Food AnimalsSeveral business leaders, including the CEO of Chipotle, wrote a letter to the U.S. Food and Drug Administration (FDA) requesting that the FDA increase its efforts to curtail the misuse of antibiotics in food animal production. More info |
Antibiotics in Food Animal Production |
