Posts tagged with: "fda"
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21 Jul 2011, 9:27 am
FDA Warnings The FDA issued a black box warning in March 2007 which called for lower dosages and stated that ESA use was shown to cause increased tumor growth and risk of death. [read post]
23 Feb 2013, 6:43 am
“DePuy is not recommending revision or additional follow-up in the absence of symptoms of patients with this implanted device,” the FDA stated. [read post]
8 Apr 2013, 6:16 am
News from the FDA on an enhancement supplement:The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Love Rider,” a product promoted and sold for sexual enhancement on various websites, and in some retail stores.FDA laboratory analysis confirmed that “Love Rider” contains tadalafil, the active ingredient in the FDA approved prescription drug Cialis, used to treat erectile dysfunction (ED). [read post]
5 Nov 2023, 3:34 pm
The list FDA provided on October 27 included five products branded as Leader. [read post]
5 Feb 2017, 12:17 am
FDA is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. [read post]
30 May 2018, 2:00 pm
Federal Drug Administration (FDA) recently decided to try to “shame” some pharmaceutical and biotechnology companies for failing to provide samples to companies who wish to produce generic versions of their pharmaceuticals. [read post]
8 May 2020, 9:48 am
FDA is reissuing the April 3, 2020 letter with certain revisions. [read post]
28 Jun 2013, 6:14 am
This is an ongoing battle in the United States and abroad, and the FDA will continue its criminal law enforcement and regulatory efforts,” said John Roth, director of the FDA’s Office of Criminal Investigations. [read post]
31 Jul 2019, 6:37 am
The Wall Street Journal reported the FDA on Friday held its first-ever hearing on the safety and marketing of cannabidiol, or CBD, which could lead the agency to allow the substance’s use in certain food products. [read post]
14 Apr 2021, 4:30 am
(FDA ORA Ombuds 2020 Report.) [read post]
29 May 2013, 9:03 am
Compliance with FDA warning requirements is a complete defense to both statutes, and the court ruled that, since Fosamax had been FDA-approved, the approval was a complete defense (although the failure to warn/breach of implied warranty tort claims survived, so I’m a little confused about the interaction there--is it approval or compliance with all FDA requirements that matters?). [read post]
3 Nov 2021, 1:15 pm
Federal Food and Drug Administration (FDA) recently sent a letter to the U.S. [read post]
4 Dec 2015, 4:55 am
We looked briefly on the FDA's website, but couldn't find anything about this, but given the interest, it seemed important enough to pass along.This is starting to look like the FDA is playing out the string. [read post]
3 Oct 2023, 9:00 am
This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions. [read post]
18 Jan 2023, 8:46 am
The groups argued that the FDA did not follow due process while granting approval to the drug in 2000. [read post]
3 Oct 2011, 7:48 am
Although it still hasn’t reached a final conclusion, the FDA issued a statement on September 26, 2011, that preliminary results of an independent FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives. [read post]
13 Jun 2018, 6:39 am
Food and Drug Administration (FDA) announced that they are conducting a national crackdown on e-cigarette sales to minors, especially Juul products. [read post]
16 Jun 2009, 4:46 am
As the San Francisco Examiner reports, Congress has passed a bill giving the FDA authority to regulate soft drinks. [read post]
23 Jan 2009, 9:13 am
The Government Accountability Office (GAO) recently issued a report indicating that the Food and Drug Administration (FDA) is sending Class III medical devices to market with minimal review. [read post]
8 Jun 2009, 4:19 pm
Here's an excerpt: Congress is on the verge of passing sweeping legislation that would empower the Food and Drug Administration (FDA) to regulate tobacco... [read post]
