Search for: "M.D. Janet Woodcock" Results 1 - 20 of 30
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15 Nov 2013, 5:10 am by Jon Gelman
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]
22 Dec 2009, 7:06 am by Anthony Gantous
“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]
29 Jan 2014, 6:16 pm by FDABlog HPM
The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. [read post]
13 Oct 2016, 6:12 am by m zamora
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
13 Oct 2016, 6:12 am by m zamora
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
20 Jan 2008, 10:54 pm
"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. [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]
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]
14 Apr 2009, 8:41 am
"The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. [read post]
18 Mar 2009, 11:56 am
According to Janet Woodcock, M.D., director of  the Center for Drug Evaluation and Research at FDA, by means of this action the agency hopes to convey a simple but important message:   "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk. [read post]
30 Mar 2016, 1:42 pm by Jon Gelman
“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]
17 Sep 2011, 5:43 am by Jonathan Rosenfeld
Food and Drug Administration, The New England Journal of Medicine by Janet Woodcock, M.D., Joshua M. [read post]
31 Oct 2012, 2:26 pm by Mark Zamora
“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 shortage list. [read post]
14 Oct 2019, 10:59 am by silverman_admin
Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research states,  “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. [read post]
4 May 2020, 6:34 am by Salvi, Schostok & Pritchard P.C.
“Since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. [read post]
16 Dec 2013, 11:00 am by Bill Marler
“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]