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(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]
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
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The Produce Safety Final Rule, the Foreign Supplier Verification Programs (FSVP) Final Rule and the Accredited Third-Party Certification Final Rule were issued on November 13, 2015. [4] The Sanitary Transportation of Human and Animal Food final rule was issued on April 6, 2016, [ 5 ] and the Mitigation Strategies To Protect Food Against ...