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FDA approval process 6 articles

FDA launches program to stop importation of dangerous, ineffective drugs

The Food and Drug Administration (FDA) has implemented a new pilot program designed to crack down on the import of contaminated, misbranded or unapproved drugs into the United States. The Secure Supply Chain Pilot Program will help ensure the safety of drugs manufactured outside the country, but will also help qualified drug companies in the program by expediting their approval processes so that the agency can focus on drugs not in the program that may need closer inspection to ensure safety. In order to qualify to be in the program, pharmaceutical companies must be the sponsor of a New Drug ... Read More

Congress weighs value of expedited approval process for medical devices

Medical device manufacturers are hoping lawmakers sympathize with them and their efforts to put much-needed medical devices on the market sooner for patients in need, rather than with consumer groups who say the approval process for moderate-risk medical devices is flawed and dangerous, and allows products onto the market before they have been proved safe and effective. The $350 million medical device industry spent a whopping $33 million last year and used 225 lobbyists in an effort to sway federal decision makers in their favor despite records from the Food and Drug Administration (FDA) that show that nearly 5,000 deaths in ... Read More

Woman nearly killed by bladder sling surgery lobbies for more oversight

Lena Keeton contracted a deadly flesh-eating bacteria following surgery in 2001 to implant a synthetic mesh bladder sling to treat her occasional incontinence, and has since endured 17 surgeries and ongoing medical problems as a result of the mesh. Now Keeton, who spits her time between Austin, Texas, and Miami Beach, Fla., was in Washington, D.C., last week lobbying federal officials to strengthen oversight of medical devices such as surgical mesh. The Food and Drug Administration (FDA) recently issued a warning to patients about complications with the mesh when used transvaginally to treat pelvic floor disorders, including incontinence and pelvic ... Read More

All-metal hip implant failures demand better review and regulation, legislators say

California Representative Henry Waxman of California and three other House Democrats on the Energy and Commerce Committee have petitioned Committee Republicans to investigate metal-on-metal hip implants, including DePuy’s recalled ASR systems and other possibly faulty medical devices, citing insufficient regulation as the reason why these products may have harmed so many Americans. Mr. Waxman and the other Democrats explained the “unique risks” of metal-on-metal hip implants, which an estimated 500,000 people in the United States have received. About 37,000 of those patients have received one of DePuy’s recalled ASR hip implants, and many of those patients are now suing the ... Read More

FDA launches new training program for medical device reviewers

The Food and Drug Administration (FDA) has implemented two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of the individuals tasked with reviewing pre-marketing applications at the agency’s Center for Devices and Radiological Health (CDRH). This program is just one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process, an expedited approval process granted to moderate-risk medical devices determined to be “sufficiently similar” ... Read More

DePuy hip recalls expose flaws in U.S. health care system

The U.S. health care system, often celebrated domestically as the best in the world, is woefully inadequate when it comes to protecting consumers from dangerous and/or defective medical devices. The FDA, for instance, allows many medical devices to be fast-tracked through the approval process if the devices are substantially similar to already-approved devices. Then, if those devices fail and have to be recalled because they weren’t properly tested, no single registry exists that can readily tell officials how many Americans are affected and who those people are so that they can be contacted. This is the story of DePuy’s recalled ... Read More