Search results
Results from the WOW.Com Content Network
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that gives it more oversight of diagnostic tests developed by them ...
The American Clinical Laboratory Association said Monday it “has grave concerns about this rule as a matter of both policy and law. The rule will limit access to scores of critical tests ...
The act also codified FDA regulations and practice to increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. In addition, the law provided for an expanded database on clinical trials, ClinicalTrials.gov. [7]
This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. [1] It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. [2]
It also talks about the FDA citizen petition. The 1100 series includes updated rules deeming items that statutorily come under the definition of "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco. [5]
[5] The U.S. congressional review concluded medical devices would require actual device experience in a clinical setting and sufficient reporting of adverse data events. The legislation would encompass medical devices demonstrating the potential for life-threatening events and accurate adverse data collection would be required for informed ...
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
The FTC said the final rule, which takes effect around April of next year, could save consumers 53 million hours in wasted time searching for the total price of live event tickets or short-term ...