Center for Drug Evaluation and Research

Type: Organization
Name: Center for Drug Evaluation and Research
First reported Sep 30 2014 - Updated Sep 30 2014 - 1 reports

FDA imprudence hurts the consumer

By Michael Roach By Michael Roach In 1975, Bob Dylan released his popular protest song "Hurricane," which highlighted the extreme racism and racial profiling apparent in the criminal justice system. The song was Dylan's response to the imprisonment of ... [Published Individual.com - Sep 30 2014]
First reported Sep 29 2014 - Updated Sep 29 2014 - 1 reports

FDA's New Emergency Technology Team to Assist "Innovative Manufacturers"

FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and “overcoming roadblocks”.The new team will facilitate the inspection and review ... [Published Pharmaceutical Executive - Sep 29 2014]
First reported Sep 26 2014 - Updated Sep 26 2014 - 1 reports

Perspectives on Assessment, Assurance and Drug Quality: Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014 , Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about Abbreviated ... [Published Future of BioPharma - Sep 26 2014]
First reported Sep 24 2014 - Updated Sep 24 2014 - 1 reports

AtTask Secures $1 million FDA Contract

ArticlePress Release September 24, 2014Lehi –  AtTask has announced that the largest division of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER), has chosen AtTask to manage its review of drug applications. ... [Published Utah Business Magazine - Sep 24 2014]
First reported Sep 24 2014 - Updated Sep 24 2014 - 1 reports

21st Century Cures initiative discusses growing threat of antibiotic resistance

[embedded content]Politicians and health experts gathered for a Subcommittee on Health hearing on Friday to discuss the future of drug resistance and explore options to decrease this threat under the committee’s 21st Century Cures initiative.Rep. Joe ... [Published BioPrepWatch - Sep 24 2014]
First reported Sep 23 2014 - Updated Sep 23 2014 - 1 reports

AtTask Signs $1 Million Contract with U.S. Food and Drug Administration

SILICON SLOPES, Utah, Sept. 23, 2014 /PRNewswire/ -- AtTask, the leading provider of cloud-based Enterprise Work Management solutions, today announced that the largest division of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation ... [Published PR Newswire: Consumer Products & Retail - Sep 23 2014]
First reported Sep 19 2014 - Updated Sep 19 2014 - 1 reports

Perspectives on Assessment, Assurance and Drug Quality

In today's featured presentation from Biopharmceutical Development and Production Week 2014 , Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the FDA’s work ... [Published Future of BioPharma - Sep 19 2014]
First reported Sep 17 2014 - Updated Sep 18 2014 - 1 reports

New relief for opiod induced constipation gets go ahead from FDA

Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain has been given approval by the U.S. Food and Drug Administration according to Dr Julie Beitz, director of the Office of Drug Evaluation III ... [Published Examiner.com - Sep 17 2014]
First reported Sep 16 2014 - Updated Sep 17 2014 - 1 reports

FDA approves AstraZeneca's Movantik

SILVER SPRING — The Food and Drug Administration on Tuesday announced approval for Movantik (naloxegol), a treatment for opioid-induced constipation in adults. Opioids are used for the treatment and management of pain, but a common side effect associated ... [Published Drug Store News - Sep 16 2014]
First reported Sep 17 2014 - Updated Sep 17 2014 - 1 reports

FDA Announces "Purple Book"

By Paul Tully -- The new phone book is here? No, but close. The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs. The list will be supplemented with approved biosimilar alternatives ... [Published Patent Docs - Sep 17 2014]
First reported Sep 15 2014 - Updated Sep 15 2014 - 1 reports

Monday Moves: September 15

Share this article:MANUFACTURERPurdue Pharma announced that  Susie Robinson , former head of human resources at Lumeris, has joined the company as Vice President of Human Resources. Prior to Lumeris, Robinson was the chief human resources officer at Infogroup, ... [Published Medical Marketing And Media - Sep 15 2014]
First reported Sep 02 2014 - Updated Sep 02 2014 - 1 reports

FDA Looking for New Head of CDER Communications

For those who have had the pleasure of working with Julie Zawisza in the past, the news is that she has moved on to a new role at FDA.  That means her former position in communications at the Center for Drug Evaluation and Research is open and FDA is ... [Published Eye on FDA - Sep 02 2014]

Quotes

...The song was Dylan's response to the imprisonment of black middleweight boxer Rubin "Hurricane Carter who was wrongfully convicted of a murder. This is expressed in the ninth verse, "No one doubted that he pulled the trigger. And though they could not produce the gun, the DA said he was the one who did the deed, and the all-white jury agreed." Obviously, conflict of interest in situations where the government or legal system is supposed to be an impartial arbiter has been a chronic issue in America."
...time to develop meaningful and thoughtful comments, especially in light of the concurrent comment period with another draft guidance entitled "Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices" published elsewhere in this volume of the Federal Register
"It was like getting a shot of adrenaline first thing in the morning," Lynn said. "It would make my hands shake, my heart would pound."

More Content

All (143) | News (119) | Reports (0) | Blogs (23) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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DEA Reschedules Hydrocodone Combination Products [Published News and Journals - 13 hours ago]
Bilirakis Questions FDA About Biomarkers [Published Rep. Gus Bilirakis - YouTube Channel - 15 hours ago]
FDA imprudence hurts the consumer [Published Individual.com - Sep 30 2014]
FDA's New Emergency Technology Team to Assist "... [Published Pharmaceutical Executive - Sep 29 2014]
Internet/Social Media Platforms: Correcting Ind... [Published HispanicBusiness.com - Sep 29 2014]
At White House, Prescription Drug Protesters Ca... [Published ABC News - Sep 29 2014]
Patient-Focused Drug Development Public Meeting... [Published Pharmacy Choice - Sep 26 2014]
Perspectives on Assessment, Assurance and Drug ... [Published Future of BioPharma - Sep 26 2014]
FDA releases draft guidance updating agency pol... [Published Lexology - Sep 25 2014]
Novel Antibiotics Need a Dose of Incentives [Published The Morning Consult - Sep 25 2014]
Questions Raised Over Brand Name Rx Drugs vs. G... [Published ABC News - Sep 25 2014]
AtTask Secures $1 million FDA Contract [Published Utah Business Magazine - Sep 24 2014]
Purple Is the New Orange [Published JD Supra - Sep 24 2014]
21st Century Cures initiative discusses growing... [Published BioPrepWatch - Sep 24 2014]
AtTask Signs $1 Million Contract with U.S. Food... [Published CW Atlanta - Sep 23 2014]
AtTask Signs $1 Million Contract with U.S. Food... [Published PR Newswire: Consumer Products & Retail - Sep 23 2014]
FDA Approves Type 2 Diabetes Drug to Normalize ... [Published Pharmaceutical Manufacturing Magazine - Sep 22 2014]
PhUSE announces Final List of Industry Influenc... [Published Digital Journal - Sep 22 2014]
FDA: Don’t Use ‘Sterile’ Products From Downing ... [Published Pharmacy Practice News - Sep 20 2014]
FDA approves once-weekly GLP-1 receptor agonist... [Published Drugtopics.com - Sep 20 2014]
FDA Approves Trulicity To Treat Type 2 Diabetes [Published Pharmacy Practice News - Sep 19 2014]
FDA committees withhold approval of oral testos... [Published Orthopedics Today - Sep 19 2014]
Why Reducing Antibiotic Resistance Is Harder Th... [Published Time - Sep 19 2014]
Why Reducing Antibiotic Resistance Is Harder Th... [Published TIME.com - Sep 19 2014]
Eli Lilly's Trulicity approved by FDA [Published Drug Store News - Sep 19 2014]
Perspectives on Assessment, Assurance and Drug ... [Published Future of BioPharma - Sep 19 2014]
It's A First — Parent Advocacy Group Offers FDA... [Published Neurology Today - Sep 19 2014]
OVERNIGHT REGULATION: Biz to unleash assault on... [Published The Hill - Sep 18 2014]
FDA approves dulaglutide to treat type 2 diabetes [Published Orthopedics Today - Sep 18 2014]
FDA approves Trulicity to treat type 2 diabetes [Published U.S. Food and Drug Administration - Sep 18 2014]
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Bilirakis Questions FDA About Biomarkers [Published Rep. Gus Bilirakis - YouTube Channel - 15 hours ago]
<a style="font-size: 15px; font-weight: bold;font-decoration: none;" href="http://www.youtube.com/watch?v=xBR4ngVjrQU&feature=youtube_gdata"&gt;Bilirakis Questions FDA About Biomarkers Rep. Gus Bilirakis questions Dr. Woodcock, Director of FDA's Center ...
Perspectives on Assessment, Assurance and Drug ... [Published Future of BioPharma - Sep 26 2014]
In today's featured presentation from Biopharmaceutical Development and Production Week 2014 , Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about Abbreviated ...
AtTask Signs $1 Million Contract with U.S. Food... [Published PR Newswire: Consumer Products & Retail - Sep 23 2014]
SILICON SLOPES, Utah, Sept. 23, 2014 /PRNewswire/ -- AtTask, the leading provider of cloud-based Enterprise Work Management solutions, today announced that the largest division of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation ...
Why Reducing Antibiotic Resistance Is Harder Th... [Published TIME.com - Sep 19 2014]
Just a day after President Obama announced an executive order to create a task force and action plan for confronting antibiotic resistance, the House Energy & Commerce Committee held a hearing on antibiotic resistance and how to foster new drug development. ...
Perspectives on Assessment, Assurance and Drug ... [Published Future of BioPharma - Sep 19 2014]
In today's featured presentation from Biopharmceutical Development and Production Week 2014 , Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the FDA’s work ...
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