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19 Sep 2008, 7:13 am
Rather, Wyeth and the F.D.A. argue that the company could not comply with both federal law, given its requirement that the agency approve drug labels, and the jury’s verdict, which punished Wyeth for not using a different one. [read post]
18 Sep 2008, 7:10 am
Kessler, a former commissioner of the F.D.A. [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]
23 Jul 2008, 12:36 pm
" GlaxoSmithKline could put SRT501, its resveratrol formulation, on the market right away, selling it as a natural compound and nutritional pharmaceutical that does not require approval by the F.D.A. [read post]
19 Jul 2008, 5:52 pm
Just this week, the F.D.A. chided the Red Cross for distributing more than 200 blood products that the organization itself had identified as problematic but failed to intercept before distribution. [read post]
2 Jul 2008, 8:08 pm
  Evidence produced during a lawsuit against Bayer over the drug Baycol illustrates Bayer's apparently longstanding philosophy regarding drug side effects: A note written by a Bayer official read, ''If the F.D.A. asks for bad news, we have to give, but if we don't have it, then we can't give it to them. [read post]
19 Jun 2008, 11:06 am
Bek says The Ritz gets its tomatoes from a local grower who uses safe, F.D.A. approved methods to water crops. [read post]
6 Jun 2008, 2:40 pm
Several months ago the New York Times opined, "The F.D.A. in Crisis: It Needs More Money and Talent," That had come shortly after Congress was told that the FDA wasn't able to... [read post]
2 Jun 2008, 11:56 am
But the very last paragraph of the article said this:The government argues that the F.D.A. competently oversees the drug and device markets, and should not be second-guessed by courts. [read post]
8 Apr 2008, 6:00 am
" The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. [read post]
29 Mar 2008, 7:48 am
Justice Scalia's faith in the F.D.A. far outstrips our own. [read post]
13 Mar 2008, 8:00 am
Either they will support legislation that denies F.D.A. preemption or they will not. [read post]
10 Mar 2008, 6:44 am
Prior to the the Bush administration, the F.D.A. always held the position that lawsuits provided patients with additional protection besides the agency's scrutiny. [read post]
9 Mar 2008, 12:25 am
"Dairy farmer choice to use a variety of F.D.A. [read post]
2 Mar 2008, 12:33 am
Herrmann, who writes a blog about these issues (druganddevicelaw.blogspot.com), said Thursday that the decision put the onus on medical device companies and the F.D.A. to prove they can protect patients without the threat of product-injury lawsuits. [read post]
22 Feb 2008, 1:30 pm
The device won F.D.A. premarket approval in 1994, two years before the incident. [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]
20 Feb 2008, 7:25 pm
Tomorrow's paper will also contain a news analysis headlined "Justices Add Legal Complications to Debate on F.D.A.'s Competence. [read post]