FDA amendments give agency broad powers over drug safety, ad fines.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Sept. 27 gained broad new powers to ensure the safety of prescription drugs prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, used by millions of Americans under a bill President Bush signed into law, "The Washington Washington, town, England Washington, town (1991 pop. 48,856), Sunderland metropolitan district, NE England. Washington was designated one of the new towns in 1964 to alleviate overpopulation in the Tyneside-Wearside area. Post" reported. At its core, the new law renews for five years programs to collect fees from drug and medical device manufacturers. The industry money accounts for about one-quarter of FDA's overall budget, defraying the cost of reviewing products that need agency approval. In part, the legislation shifts more of FDA's attention from experimental drugs pending approval to those already are on the market, and gives the agency more power to act when worrisome problems emerge. It gives FDA the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear, said FDA commissioner Andrew von Eschenbach Eschenbach may refer to: Places in Germany
The legislation further requires companies to publicly release results of all clinical trials that show how well their approved drugs In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. performed. Not yet approved drugs could be subject to the requirement later. Still, how FDA's Amendments Act of 2007 will change the agency remained unclear, beyond the expected hiring of several hundred new employees. FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines This article or section contains self-references. For other uses of "Timeline", see Timeline (disambiguation). The following is an index of timelines found on Wikipedia. , before deciding how to implement them. The fine-print list of actions FDA must take runs more than 10 pages, said Randall Lutter, the agency's deputy commissioner for policy. The legislation does spell out that FDA will be able to fine drug companies for not completing follow-up follow-up, n the process of monitoring the progress of a patient after a period of active treatment. follow-up subsequent. follow-up plan studies on their drugs after they've won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered. The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in various fees next year. It also requires FDA to step up its active surveillance for new safety issues with drugs. That system traditionally has been largely passive. To review the full Amendments Act please visit: http://www.fda.gov/oc/initiatives/advance/fdaaa.html. |
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion