Testing new antibiotics to treat highly resistant bacterial infections is especially difficult, since only a small number of patients contract such infections or meet the requirements to participate in clinical trials. Following are examples of hard-to-treat pathogens that present the greatest unmet needs today, and the types of drugs that are most likely to address them.More info
WASHINGTON—The U.S. Senate today joined the House in passing Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the U.S. Food and Drug Administration’s drug and device reviews.
"We commend the Senate for passing the bipartisan FDA Safety and Innovation Act, and the Health, Education, Labor and Pensions Committee for its leadership throughout this process,” said Allan Coukell, director of medical programs at the Pew Health Group.
"This legislation will, for the first time, enable the FDA to:
- Regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications
- Spur the development of new antibiotics specifically to treat serious and life-threatening infections; and
- Actively monitor the safety of high-risk medical devices already on the market and promote innovation by streamlining the review process for new low- and medium-risk devices.
"We applaud Republicans and Democrats in both chambers of Congress for collaborating with each other and with businesses, consumer and patient advocates, and the medical community to develop and pass this bill. We now urge President Obama to sign and implement this legislation as swiftly as possible."
- Date added:
- Jun 26, 2012
The President’s Council of Advisors on Science and Technology held a public meeting on April 4 to discuss the issue of antimicrobial resistance. Drug safety and innovation director Elizabeth Jungman testified on the need to spur the development of new antibacterial drugs.More info