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28 Mar 2018, 6:37 am
The Times adds, “The documents indicate that several suicides and suicide attempts in early clinical trials that were attributed to patients on a placebo – and which made Paxil [paroxetine look safer by comparison – should not have been counted, and that an F.D.A. reviewer later told the company as much. [read post]
18 Sep 2010, 3:14 am
The move places the fate of Meridia, which is expected to generate $30 million in domestic sales this year, with the F.D.A., which will weigh the panel’s advice when making a final decision. [read post]
27 Jan 2009, 1:20 pm
Officials will also have to make clear that the Bush administration's practice of distorting science and weakening regulation to favor industry also is over. ...The next F.D.A. commissioner should ensure that past decisions on medical devices were properly made. [read post]
8 Aug 2008, 2:55 am
While a physician is free to use a medical device for any means, F.D.A. guidelines say drug companies and device makers may not promote their products for unapproved purposes or patient categories, like prescribing adult medicines for children. [read post]
26 Apr 2013, 2:47 am
” The researchers argued that web search monitoring “would be a valuable tool for the F.D.A. to add to its current system for tracking adverse effects. [read post]
1 Oct 2010, 9:59 am
Novartis pays another $237.5 million resolving civil allegations that it promoted its drug Trileptal for uses not approved by the F.D.A. [read post]
30 Jul 2019, 10:55 am
U.S. regulators, the New York Times reported, lagged their European counterparts by almost a year in acting to protect women seeking cosmetic and reconstructive procedures involving the Allergan implant: “Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. [read post]
3 Aug 2009, 3:35 pm
" The announcements follow Thursday's passage of a House bill "to strengthen the F.D.A.'s oversight of food safety by giving it added powers and mandating more frequent inspections of food processing plants. [read post]
23 Apr 2012, 3:00 am
This latest article makes this assertion: Republican Senator Rick Bertrand of Sioux City objected to a TV ad which claimed Bertrand’s company had been singled out by the F.D.A. for the “marketing of dangerous drugs to children. [read post]
17 Sep 2010, 5:13 pm
The F.D.A. later demanded that a formal recall be announced. [read post]
18 Sep 2010, 2:17 am
Six urged restricted sales and strong “black box” warning, while two others said the warning and patient monitoring were enough.The move places the fate of Meridia, which is expected to generate $30 million in domestic sales this year, with the F.D.A., which will weigh the panel’s advice when making a final decision. [read post]
22 Feb 2008, 12:36 pm
Yesterday's issue had a news analysis, "Justices Add Legal Complications to Debate on F.D.A.'s Competence. [read post]
25 May 2011, 12:22 pm
Avastin will not disappear because of the F.D.A. decision. [read post]
24 Aug 2010, 5:52 am
Robert Smith, a former F.D.A. device reviewer explained that the “F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making [the] industry happy, people continue to die. [read post]
18 Dec 2010, 3:12 am
Further, "In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. [read post]
20 Feb 2009, 11:42 am
"The F.D.A. has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can't sue companies for redress. [read post]
24 Oct 2009, 9:32 am
The F.D.A. actually condones a certain percentage of “natural contaminants” in our food supply — meaning, among other things, bugs, mold, rodent hairs and maggots.In its (falsely) reassuringly subtitled booklet “The Food Defect Action Levels: Levels of Natural or Unavoidable Defects in Foods That Present No Health Hazards for Humans,” the F.D.A. [read post]
23 Jan 2011, 5:19 pm
The problem stems from the fact that current rules do not require device producers to notify the F.D.A. when they bundle together components from approved and unapproved devices, Mark Melkerson, an FDA official, acknowledged. [read post]
10 Jan 2009, 7:44 pm
Fresh eggs are under the jurisdiction of the F.D.A.; egg products go to Agriculture. [read post]
25 Dec 2022, 3:13 pm
The F.D.A. revised the leaflets inserted in packages of pills to say that the medication “works before release of an egg from the ovary,” meaning that it acts before fertilization, not after. [read post]
