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"After 15 months of delay, the Centers for Medicare & Medicaid Services has finally released the long-awaited Sunshine Act rule, which establishes procedures for gathering and publishing data containing financial ties between physicians, teaching hospitals and drug and device makers, as well as group purchasing organizations."
More infoIn 2007, an agency panel found that the FDA’s "scientific workforce does not have sufficient capacity and capability" and the agency is "not positioned to meet current or emerging regulatory responsibilities." The Pew Charitable Trusts wanted to know if that’s still the case, and asked the Partnership for Public Service to find out. "FDA has made progress," says the Partnership’s report, but the agency "continues to have significant workforce and management challenges in the scientific and medical arenas that need to be addressed."
More infoThe U.S. Food and Drug Administration (FDA) employs thousands of scientists, physicians, and engineers to fulfill its mission to protect and promote the public health. However, high turnover and difficulties recruiting staff hamper the FDA’s ability to ensure the safety and effectiveness of drugs and medical devices, according to a report from the Partnership for Public Service (PPS).
More info"Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market."
More infoPassed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.
More info"The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms."
More info"A Food and Drug Administration bill designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home, is headed to the president’s desk after an overwhelming approval in the U.S. Senate."
More infoOn Wednesday, the House easily approved legislation that would reauthorize the FDA's user-fee program for brand-name drugs and medical devices, and expand that program to cover biosimilars and generic drugs.
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"Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs."
More infoWASHINGTON—The U.S. Food and Drug Administration (FDA) approves new drugs more quickly than its counterparts in Europe and Canada, according to a new paper, “Regulatory Review of Novel Therapeutics Comparing FDA, EMA and Health Canada,” published online on May 16
More info"As FDA user fee legislation heads to the House floor, a key Democratic lawmaker called for antibiotic incentive to be focused on serious and life-threatening infections and an HHS directive to work on stewardship programs while the lead sponsor of antibiotic incentives pushed back against attempts to change the incentive structure outlined in the Generating Antibiotic Incentives Now section of the bill."
More info"House lawmakers said they will continue efforts to narrowly tailor antibiotic incentives and clarify an online pharmacy measure before the full Energy and Commerce Committee takes up FDA user fee legislation that gained bipartisan subcommittee backing Tuesday morning."
More info"The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs ... "
More info“Regulators and drugmakers need to find ways to make more clinical data openly available, since vital knowledge about fighting disease is often locked away in confidential databases, the head of the U.S. drugs watchdog said on Monday. Food and
More info“Venture capitalists are beginning to steer their investment dollars away from fledgling pharmaceutical and medical device companies, a phenomenon that will drive jobs and promising treatments overseas, according to a new survey of life sciences investors ... "
More infoFive years after an agency panel finds "sufficient capacity and capability" issues, a new report on the FDA workforce sees some progress but notes "significant workforce and management challenges in the scientific and medical arenas” that still need to be addressed.
Allan Coukell
Senior Director, Drugs and Medical Devices
The Pew Charitable Trusts
Kathleen Stratton
Director, Innovate FDA,
The Pew Charitable Trusts
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