Posts tagged with: "fda"
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17 Mar 2020, 1:32 pm
(877) 917-5250 Recent FDA Recalls Not all FDA recalls are given press releases or are posted on the FDA recall list on the agency’s website. [read post]
1 Sep 2013, 8:38 pm
Noonan of McDonnell Boehnen Hulbert & Berghoff will provide a drill-down on the FDA's 2013 draft guidance to navigate the complex standards of the FDA's Biosimilar Approval Pathway and address the most challenging issues around patent and exclusivity in developing, marketing, and obtaining approval for biosimilars in and outside the U.S. [read post]
23 Apr 2008, 2:42 am
From various sites: FDA reps said they have new evidence linking many serious adverse reactions and deaths among patients given the blood thinner heparin to a man-made contaminant introduced during production in China.The FDA traces the contaminant to 12 different Chinese companies and has been found in heparin batches shipped to 11 nations, all of it from China. [read post]
20 Nov 2008, 4:09 pm
The Committee sent a letter to the FDA on October 8, 2008, requesting a number of documents relating to the FDA’s inspection of the Digitek factory. [read post]
15 May 2009, 7:20 am
Food and Drug Administration (FDA), that are only allowable on FDA-approved medications. [read post]
1 May 2018, 9:00 am
FDA can take a variety of enforcement measures, not limited to warning letters. [read post]
7 Aug 2008, 3:27 am
As stated in the Report: Date FDA Received 05/19/2006 Is This An Adverse Event Report? [read post]
19 Oct 2023, 9:05 pm
The FDA continues to make significant progress in our nutrition efforts, which can help combat the diet-related disease epidemic. [read post]
28 Jun 2020, 10:00 pm
Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date. [read post]
28 Jun 2020, 10:00 pm
Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date. [read post]
17 Feb 2021, 11:37 pm
The post How Does FDA Regulate Direct-to-Consumer Tests appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law. [read post]
11 Jul 2012, 7:02 am
On July 10, the Food and Drug Administration (FDA) released a proposed rule on medical device labeling. [read post]
28 Jun 2020, 10:00 pm
Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date. [read post]
8 Sep 2021, 9:25 pm
The post Dietary Supplement Claims: Avoid FDA Enforcement Crosshairs appeared first on Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law. [read post]
28 Jun 2020, 10:00 pm
Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date. [read post]
28 Jun 2020, 10:00 pm
Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date. [read post]
14 Apr 2005, 9:06 am
[JURIST] A federal judge in Utah has struck down the Food and Drug Administration ban on the weight-loss supplement ephedra, pulled off the market by the FDA in April 2004 [FDA press release] after it was found to be linked to some 155 deaths. [read post]
10 Sep 2008, 5:32 pm
The site, "Be Smart About Prescription Drug Advertising," is hosted by the FDA's Center for Drug Evaluation and Research and was developed by the FDA in partnership with EthicAd. [read post]
11 Jul 2012, 7:02 am
On July 10, the Food and Drug Administration (FDA) released a proposed rule on medical device labeling. [read post]
28 Jun 2020, 10:00 pm
Below we provide brief summaries of key points from FDA’s drug and biologic COVID-19 guidance to date. [read post]
