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Center for Drug Evaluation and Research

Type: Organization

Name: Center for Drug Evaluation and Research

First reported 12 hours ago - Updated 12 hours ago - 1 reports

Margaret Hamburg

A birth control double standard

In the uproar about making the morning-after contraceptive known as Plan B available to our daughters, there has been no similar outcry about condoms and our sons. Anyone of any age can walk into a drugstore as well as most grocery and big-box stores ... [Published Los Angeles Times - 12 hours ago]

Entities: Sex, nonprescription, Center for Drug Evaluation and Research, Margaret Hamburg

First reported 18 hours ago - Updated 18 hours ago - 1 reports

Salem College

Alumna, consultant Lucy Rose to speak at Salem College graduation

Carson Capshaw-Mack/Winston-Salem Journal Winston-Salem JournalJanet L. “Lucy” Rose, one of the most sought-after consultants in the pharmaceutical industry, will address students at Salem College’s commencement ceremony at 10 a.m. on Saturday, May 2 ... [Published Winston-Salem Journal - 18 hours ago]

Entities: Salem College, Physician Assistant, FDA Food & Drug Administration, Center for Drug Evaluation and Research

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Submission of NDA/Abbreviated NDA Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program

body: The FDA has launched a new pilot program that will use a common data format to automate part of the submission process for Field Alert Reports (FARs). Under current regulations, all holders of approved new drug applications (NDAs) must submit FARs ... [Published AAPS Pharmceutica - May 17 2013]

Entities: New Drug Application, Extensible Markup Language (XML), PDF

First reported May 15 2013 - Updated May 16 2013 - 1 reports

Rep. Bob Latta plan to thwart fake drugs passes House of Representatives committee

Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, says counterfeit drugs raise significant public health concerns and said security breaches at any part of the supply chain “could lead to dangerous and even deadly outcomes for ... [Published Business - cleveland.com - May 15 2013]

Entities: Bob Latta, Fake, Drugs

First reported May 15 2013 - Updated May 16 2013 - 3 reports

Bayer's radiation prostate cancer drug bags US nod

US regulators have approved Bayer's Xofigo as a treatment for prostate cancer, just three months after it was assigned a priority review.The US Food and Drug Administration has issued a green light for the injection for use in men with symptomatic late-stage ... [Published Pharma Times - May 16 2013]

Entities: Prostate Cancer, antineoplastic, Radiation

First reported May 15 2013 - Updated May 15 2013 - 1 reports

Frank Pallone

House panel approves drug-tracking bill

A House panel on Wednesday advanced legislation along party lines to increase the tracking of prescription drugs.The Safeguarding America's Pharmaceuticals Act of 2013 requires the Food and Drug Administration (FDA) to propose new rules to keep consumers ... [Published The Hill - May 15 2013]

Entities: Frank Pallone, FDA Food & Drug Administration, Janet Woodcock, Jan Schakowsky

First reported May 13 2013 - Updated May 14 2013 - 2 reports

FDA Food & Drug Administration

What Companies Will This FDA Decision Impact?

The U.S. Food and Drug Administration ruled Friday that a new version of Opana ER, a painkilling drug, does not deter drug abuse better than earlier versions. Companies will be allowed to make generic versions of the older Opana ER, reports The Wall ... [Published Wall St. Cheat Sheet - May 13 2013]

Entities: Opana ER, FDA Food & Drug Administration, anodyne, Actavis, Abuse

First reported May 13 2013 - Updated May 13 2013 - 1 reports

Sen. Warren's Remarks at HELP Committee Hearing on Pharmaceutical Compounding

WASHINGTON, DC - At a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing today (5/9), Sen. Warren discussed the ongoing public health threat posed by inadequate regulation of the pharmaceutical compounding industry. Massachusetts was ... [Published Zecco - May 13 2013]

Entities: New England Compounding Center Inc, HEALTH THREAT, American Society of Health-System Pharmacists, National Association of Boards of Pharmacy, Janet Woodcock

First reported May 09 2013 - Updated May 10 2013 - 3 reports

Senators say they're close to writing a final pharmacy compounding bill

And a top federal drug official, who has studied a fungal meningitis outbreak that has killed 55 and sickened about 700 since the fall, said a draft bill co-written by Kansas Sen. Pat Roberts could not only improve drug safety, but save lives as well ... [Published KansasCity.com - May 09 2013]

Entities: Pat Roberts, Tom Harkin, FDA Food & Drug Administration

First reported May 07 2013 - Updated May 08 2013 - 2 reports

FDA warns pregnant women vs migraine drug

InterAksyon.comThe online news portal of TV5WASHINGTON DC - The United States Food and Drug Administration has warned pregnant women against the use of valproate sodium products for the prevention of migraine headaches.The FDA said a recent study has ... [Published Interaksyon - May 08 2013]

Entities: Megrim, Pregnancy, Drugs, Russell Katz, Valproate

First reported May 06 2013 - Updated May 07 2013 - 4 reports

FDA Warns Pregnant Women Not To Use Some...

redOrbit Staff & Wire Reports – Your Universe OnlineThe US Food and Drug Administration (FDA) is warning women who are of childbearing age not to use several varieties of migraine medicine which could decrease the intelligence of their babies if taken ... [Published Red Orbit - May 07 2013]

Entities: Pregnancy, Drugs, Depakote, Megrim

First reported May 02 2013 - Updated May 02 2013 - 2 reports

The Morning-After Pill Should Be Available to All Ages

At what age should girls be allowed to buy the “morning after” pill on their own? The answer, it seems, depends on whether the question is framed by scientific principle or by individual moral perspectives.After reviewing research and consulting scientific ... [Published Bloomberg - May 02 2013]

Entities: Center for Drug Evaluation and Research, nonprescription, White House, Drugs, District Judge

Quotes

...Food and Drug AdministrationDrug Administration Commissioner Margaret Hamburg, who is a physician, concluded that "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential."

A birth control double standard [Published Los Angeles Times - 12 hours ago]

...of the Division of Gastroenterology and Inborn Errors Products in the FDA's CenterCenter for Drug Evaluation and Research, said in a press release. "It is critical that patients suffering from the serious and painful symptoms of ulcerative colitis have additional treatment options since patients experience the effects of the disease and respond to treatments differently."

FDA Approves Simponi to Treat A Chronic Bowel Disease [Published ITechPost - May 17 2013]

...According to Bayer "Radium 223 mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha emitters may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium 223 is less than 100 micrometers, which may limit damage to the surrounding normal tissue."

Advanced Prostate Cancer Drug Xofigo Approved By FDA [Published MediLexicon - May 17 2013]

...oral capsules," said Russell Katz, M D , director of the pision of Neurology Products in the FDA's CenterCenter for Drug Evaluation and Research. "Nymalize is a liquid that is administered orally, or via nasogastric tube or gastric tube, and there is no need for a needle to be used, which is what caused past medication errors."

FDA Approves Nymalize for Use In Certain Brain Hemorrhage Patients [Published RxList - May 17 2013]

More Content

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A birth control double standard [Published Los Angeles Times - 12 hours ago]
Alumna, consultant Lucy Rose to speak at Salem ... [Published Winston-Salem Journal - 18 hours ago]
FDA Approves Simponi to Treat A Chronic Bowel D... [Published ITechPost - May 17 2013]
The Personalized Medicine Coalition's Ninth Ann... [Published Reuters - May 17 2013]
Advanced Prostate Cancer Drug Xofigo Approved B... [Published MediLexicon - May 17 2013]
Anesthetic and Analgesic Drug Products Advisory... [Published Zecco - May 17 2013]
FDA Approves Nymalize for Use In Certain Brain ... [Published RxList - May 17 2013]
Submission of NDA/Abbreviated NDA Field Alert R... [Published AAPS Pharmceutica - May 17 2013]
FDA: Lower Ambien's dose to prevent drowsy driving [Published MyFox New York - May 17 2013]
Radium-223 Gets Early FDA Nod for Bone Mets in ... [Published Cancernetwork.com - May 17 2013]
FDA approves radiopharmaceutical to treat advan... [Published Dotmed - May 16 2013]
GOP chairman promises drug-tracking law by August [Published Congressman Jim Matheson - May 16 2013]
FDA Approves Simponi to Treat Ulcerative Colitis [Published eMedicine Health - May 16 2013]
FDA: Lower Ambien's dose to prevent drowsy driving [Published KSWO - May 16 2013]
FDA: Lower Ambien's dose to prevent drowsy driving [Published KGWN TV - May 16 2013]
Simponi injection gets FDA approval to treat ad... [Published News-Medical.Net - May 16 2013]
FDA: lower ambien's dose to prevent drowsy driving [Published Medical Xpress - May 16 2013]
FDA Approves Xofigo For Treatment Of Advanced P... [Published StudentNews.ie - May 16 2013]
Bayer's radiation prostate cancer drug bags US nod [Published Pharma Times - May 16 2013]
Advanced Prostate Cancer Rx Approved [Published Daily Rx - May 16 2013]
FDA approves radiotherapy for metastatic prosta... [Published Oncology Report - May 16 2013]
FDA Approves Xofigo for Advanced Prostate Cancer [Published American Cancer Society - May 16 2013]
Xofigo Approved for Advanced Prostate Cancer [Published Pharmacy Practice News - May 15 2013]
FDA approves Simponi to treat ulcerative colitis [Published FiercePharma - May 15 2013]
FDA Approves New Drug to Fight Advanced Prostat... [Published WebMD - May 15 2013]
FDA: Lower Ambien's Dose to Prevent Drowsy Driving [Published WebMD - May 15 2013]
FDA Approves New Drug for Advanced Prostate Cancer [Published HealthNewsDigest.com - May 15 2013]
Rep. Bob Latta plan to thwart fake drugs passes... [Published The Plain Dealer - May 15 2013]
Rep. Bob Latta plan to thwart fake drugs passes... [Published Business - cleveland.com - May 15 2013]
House panel approves drug-tracking bill [Published The Hill - May 15 2013]

Blogs

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Rep. Bob Latta plan to thwart fake drugs passes... [Published Business - cleveland.com - May 15 2013] Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, says counterfeit drugs raise significant public health concerns and said security breaches at any part of the supply chain “could lead to dangerous and even deadly outcomes for ...
What Companies Will This FDA Decision Impact? [Published Wall St. Cheat Sheet - May 13 2013] The U.S. Food and Drug Administration ruled Friday that a new version of Opana ER, a painkilling drug, does not deter drug abuse better than earlier versions. Companies will be allowed to make generic versions of the older Opana ER, reports The Wall ...
What Companies Will This FDA Decision Impact? [Published Wall St. Cheat Sheet - May 13 2013] The U.S. Food and Drug Administration ruled Friday that a new version of Opana ER, a painkilling drug, does not deter drug abuse better than earlier versions. Companies will be allowed to make generic versions of the older Opana ER, reports The ...
Obama Administration Reflexively Lies About Pla... [Published Hit & Run - May 02 2013] <p><img alt="Plan B" height="141" src="http://cloudfront-media.reason.com/mc/_external/2013_05/plan-b-1.jpg?h=141&w=220" title="Lies, damned lies, and politics!\|\|\|Credit: Princeton" width="220" style="float: right;"/>In April, a federal court ordered ...
Emily Arrowood: Fox's Attack On FDA's Emergency... [Published Media Matters for America - County Fair - May 01 2013] Fox News and Rush Limbaugh are teaming up to demonize the Food and Drug Administration's decision to lower the age requirement for access to over-the-counter emergency contraception, ignoring both the science behind the drug and the FDA's assessment ...

Press Releases

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2013 Pharmaceutical Drug Naming Trends [Published PR Newswire: Health - May 02 2013]
Chelsea Therapeutics Receives FDA Guidance for ... [Published GlobeNewswire: Acquisitions News - Feb 20 2013]
Submit Questions to Nobel Laureates and Other E... [Published CisionWire - English - Dec 06 2012]