Search for: "M.D. Janet Woodcock"
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9 Apr 2016, 8:58 am
The PSC pointed to the specific causation opinions of a clinical cardiologist, Ra-Id Abdulla, M.D., who proffered dubious differential etiologies, ruling in Zoloft as a cause of individual children’s birth defects, despite his inability to rule out truly known and unknown causes in the differential reasoning. [read post]
30 Mar 2016, 1:42 pm
“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
16 Dec 2013, 11:00 am
“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). [read post]
15 Nov 2013, 5:10 am
Sherman, M.D., M.P.H., Jun Li, J.D., Ph.D., Stephanie Shapley, M.B.A., Melissa Robb, R.N., and Janet Woodcock, M.D.N Engl J Med 2013; 369:1877-1880November 14, 2013DOI: 10.1056/NEJMp1311439ArticleMany people with serious or life-threatening illnesses for which there are no satisfactory treatments are understandably eager to gain access to new therapies and are willing to trade off greater certainty about a drug's performance for speed of access. [read post]
9 Mar 2013, 7:33 pm
On my blog I've been writing on the New England Compounding Pharmacy tragedy since the news of the fateful recall started. [read post]
31 Oct 2012, 2:26 pm
“Because the preliminary results of the FDA’s inspection raise concerns about the sterility assurance of Ameridose’s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,” explained Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.The FDA has identified some Ameridose products that currently appear on the critical… [read post]
1 Apr 2012, 8:58 am
It would also give the OGD Director (currently Keith Webber, Ph.D.) direct reporting to the CDER Director (currently Janet Woodcock, M.D.). [read post]
5 Dec 2011, 10:00 am
"This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. [read post]
17 Sep 2011, 5:43 am
Food and Drug Administration, The New England Journal of Medicine by Janet Woodcock, M.D., Joshua M. [read post]
17 Dec 2010, 11:00 am
"After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. [read post]
16 Dec 2010, 10:48 am
“After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin® be removed based on evidence from four independent studies,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
24 Sep 2010, 10:00 am
"Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. [read post]
22 Dec 2009, 7:06 am
“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
22 Dec 2009, 7:06 am
“Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
25 Nov 2009, 5:53 am
Janet Woodcock, said Congress would have to authorize a change in the existing monitoring system to make for these automatic updates. [read post]
25 Nov 2009, 5:53 am
Janet Woodcock, said Congress would have to authorize a change in the existing monitoring system to make for these automatic updates. [read post]
13 Aug 2009, 1:39 am
"The final rules balance access to promising new therapies against the need to protect patient safety and seek to ensure that expanded access does not discourage participation in clinical trials or otherwise interfere with the drug development process," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. [read post]
30 Jul 2009, 11:32 am
"The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in the agency's news release. [read post]
16 Jun 2009, 1:36 pm
Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). [read post]
9 May 2009, 2:14 am
“These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
