Posts tagged with: "fda"
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6 Mar 2020, 9:50 am
On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. [read post]
21 Oct 2008, 2:59 pm
If the Supreme Court upholds a broad view of pre-emption, restraining state courts from second-guessing safety balances performed at the FDA level, it will be advancing the cause of rational drug regulation, argues Tomas J. [read post]
1 Dec 2009, 11:32 am
From 2004 to 2008, over 50 deaths among users of Yaz and Yasmin were reported to the FDA. [read post]
5 Dec 2007, 1:38 pm
Riegel presents the question of whether federal law preempts state lawsuits against FDA approved medical devices. [read post]
24 Apr 2007, 9:30 am
The FDA draft publication entitled "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" has generated outcry and commentary.... [read post]
13 Sep 2018, 7:35 am
The US Food and Drug Administration (FDA) on Wednesday announced [press release] major policy updates and enforcement efforts on electronic cigarettes such as JUUL and their distribution and sale to teens—what the statement called the “largest coordinated enforcement effort in the FDA’s history. [read post]
8 Apr 2010, 3:24 am
FDA notices of potential food safety violations are called "official action indicated," or OAI. [read post]
29 Mar 2011, 6:48 am
The FDA’s Topamax warning came after recently released data showed that women taking the drug while pregnant were 21-times more likely to give birth to a child with cleft lips or cleft palate deformities.In addition to that warning the FDA upgraded the drug to its Pregnancy Category D. [read post]
20 Sep 2009, 12:18 am
From the FDA website: Writing About the Future of Public Health Science is a key foundation for the decisions FDA makes day on a wide-range of products affecting human and animal healthâ€â [read post]
24 Jun 2011, 5:01 am
FDA has established regulations as nonbinding guidance that FDA and the recalling firm should consider in planning and implementing a recall.The GAO reviewed 17 recalls out of 40 the FDA played a role in over a two year period. [read post]
6 Sep 2022, 8:18 pm
The FDA has approved another biosimilar, Byooviz... [read post]
19 Dec 2013, 5:08 pm
Not necessarily, according to experts at the Food and Drug Administration (FDA). [read post]
31 Aug 2011, 10:00 am
Common Side Effects of Silicone Implants Information provided by the FDA Updated Safety Data on Silicone Implants. [read post]
29 Feb 2012, 9:07 am
The final ruling from the FDA will be issued later this year. [read post]
2 Mar 2012, 1:37 pm
The FDA is warning that the use of acid reflux drugs known as proton pump inhibitors (PPI) may increase a patient’s risk of developing diarrhea. [read post]
3 Dec 2008, 8:18 pm
It is hard to figure whether the joint FDA-US Marshalls strike on Shelhigh was an attempt by the FDA to show the world that it could regulate with impunity, or whether that strike was merely an arbitrary contest between a small manufacturer and a division within the FDA. [read post]
14 Dec 2006, 4:08 am
The FDA distinguished the SSRI cases as involving state-law challenges to actual FDA decisions, and the court ultimately ruled the same way. [read post]
13 Sep 2016, 6:18 pm
On September 2, 2016, the Food and Drug Administration, FDA, enacted a final rule banning the sale of some antibacterial soaps. [read post]
5 May 2020, 1:40 pm
The Food and Drug Administration (FDA) has announced that newly manufactured coronavirus antibody tests will be subject to strict standards. [read post]
16 Nov 2018, 5:01 pm
The proposed The post FDA Announces New Regulations on E-Cigarettes and Possible Menthol Ban appeared first on Legal Reader. [read post]
