Center for Drug Evaluation and Research

Type: Organization
Name: Center for Drug Evaluation and Research
First reported 8 hours ago - Updated 2 hours ago - 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 - 8 hours ago]
First reported Sep 16 2014 - Updated 12 hours ago - 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 19 hours ago - Updated 19 hours ago - 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 - 19 hours ago]
First reported Sep 16 2014 - Updated Sep 16 2014 - 1 reports

Weight loss drug Contrave approved by FDA

The United States Food and Drug Administration has approved a new weight loss medication, Contrave, to help adults with a body mass index (BMI) of 30 or more, which would indicate obesity.Patients who are not obese but are overweight with a body mass ... [Published Examiner.com - Sep 16 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 11 2014 - Updated Sep 12 2014 - 1 reports

FDA clears Orexigen, Takeda's obesity therapy Contrave

The FDA approved Orexigen Therapeutics and Takeda's Contrave (naltrexone/bupropion) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug, which the agency rejected in 2011, is authorised ... [Published FirstWord Pharma - Sep 11 2014]
First reported Sep 09 2014 - Updated Sep 09 2014 - 1 reports

National health research forum

WHAT: Leaders from government, industry, academia and patient advocacy organizations will explore the future of R&D investments, policy trends, public-private partnerships, public health and social sciences research, global health threats and other timely ... [Published News-Medical.Net - Sep 09 2014]
First reported Sep 09 2014 - Updated Sep 09 2014 - 1 reports

FDA Establishes New "Purple Book" for Biosimilars

It may not make the New York Times’ Best Seller List, but the release of the FDA’s new book is certainly noteworthy.  The FDA today announced that they’ve published their first ever edition of the “Purple Book”, a list of licensed biological products ... [Published Future of BioPharma - Sep 09 2014]
First reported Sep 09 2014 - Updated Sep 09 2014 - 1 reports

US marshals seize non-FDA approved drugs claiming to treat liver diseases

US marshals have seized various unapproved injectable drug products from a New Jersey beauty company, including some that claimed to treat degenerative liver and brain diseases, alcoholic liver diseases, and scurvy, according to an FDA press release.Flawless ... [Published Orthopedics Today - Sep 09 2014]
First reported Sep 05 2014 - Updated Sep 05 2014 - 1 reports

FDA Approves Drug for Advanced Melanoma

(NEW YORK) -- The U.S. Food and Drug Administration (FDA) granted approval for a cancer-targeting drug for the treatment of patients with advanced melanoma.Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which prevents ... [Published KSFO-AM - Sep 05 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]
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Straight Talk: The Future of Medical and Health Research

WHAT: Leaders from government, industry, academia and patient advocacy organizations will explore the future of R&D investments, policy trends, public-private partnerships, public health and social sciences research, global health threats and other timely ... [Published Bio-Medicine - Aug 19 2014]

Quotes

...the Generic Drug User Fee Amendments of 2012, the Office of Generic Drugs (OGD) is tasked with a number of activities, including the development of "enhanced refusal to receive standards for ANDAs and other related submissions by the end of year 1 of the program. . . ." Recent data underscore the need for improvement in the quality of original ANDA submissions...
...The list will be supplemented with approved biosimilar alternatives to the biologic drugs, termed the "List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations." Inevitably given a "color" designation (following the tradition of the "Orange Book" of approved small molecule drugs), the new listing of biologics...
"Supportive care products such as Movantik can lessen the constipating side effects of opioids" said Julie Beitz, MD, director, Office of Drug Evaluation, FDA's CenterCenter for Drug Evaluation and Research, in an FDA statement
The device exclusionary clause, "does not achieve its primary intended purposes through chemical action within or on the body of man" does not expressly state how much chemical action suffices for a product to be excluded from the device definition…...

More Content

All (163) | News (142) | Reports (0) | Blogs (20) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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New relief for opiod induced constipation gets ... [Published Examiner.com - 8 hours ago]
Draft Guidance for Industry on Abbreviated New ... [Published Pharmacy Choice - 11 hours ago]
FDA approves AstraZeneca’s Movantik for opioid-... [Published Pharma Letter - 12 hours ago]
FDA Announces "Purple Book" [Published Patent Docs - 19 hours ago]
FDA Hosts Meeting to Put Pediatric Drug Develop... [Published FDA Law Blog - 23 hours ago]
FDA approves Movantik for opioid-induced consti... [Published Orthopedics Today - Sep 16 2014]
FDA approves AstraZeneca's Movantik [Published Drug Store News - Sep 16 2014]
FDA Approves Movantik for Opioid-Induced Consti... [Published Pharmacy Practice News - Sep 16 2014]
FDA Okays Naloxegol (Movantik) in Opioid-Induce... [Published Diabetes Care - Sep 16 2014]
FDA Approves AstraZeneca’s Movantik for Opioid-... [Published Pharmacy Times - Sep 16 2014]
FDA approves Movantik for opioid-induced consti... [Published Ein News - Sep 16 2014]
Weight loss drug Contrave approved by FDA [Published Examiner.com - Sep 16 2014]
Drug-Device Apple Cart Upset Again [Published Baker & Daniels - Sep 16 2014]
Monday Moves: September 15 [Published Medical Marketing And Media - Sep 15 2014]
FDA Approves Weight Management Drug Contrave [Published Pharmacy Practice News - Sep 15 2014]
FDA Approves Pembrolizumab for Advanced Melanoma [Published The ASCO Post - Sep 15 2014]
Advisory Committee recommends approval of PTH t... [Published Orthopedics Today - Sep 15 2014]
Data Integrity Key to GMP Compliance [Published PharmTech.com - Sep 15 2014]
New weight-loss drug, Contrave, still requires ... [Published Examiner.com - Sep 13 2014]
Keytruda found to be key in treating advanced m... [Published Examiner.com - Sep 13 2014]
Novartis LCZ696: 'New Wonder Drug' OR 'Old Para... [Published Seeking Alpha - Sep 12 2014]
FDA at last approves weight-management drug Con... [Published Pharma Letter - Sep 12 2014]
Global Healthcare Stakeholders to Gather in Aus... [Published Minyanville - Sep 11 2014]
FDA-Approved Weight Loss Pills See Lukewarm Sal... [Published International Business Times - Sep 11 2014]
Feds okay weight-management drug Contrave [Published Consumer Affairs - Sep 11 2014]
FDA Approves New Obesity Drug [Published US News & World Report - Sep 11 2014]
FDA Approves Orexigen's Contrave For Obesity Tr... [Published BioPortfolio - Sep 11 2014]
FDA Approves Rx for Weight Loss [Published Daily Rx - Sep 11 2014]
FDA Approves Combination Adjunct Therapy for Ch... [Published Pharmacy Times - Sep 11 2014]
Orexigen's Obesity Drug Gets FDA Approval [Published Bidness Etc - Sep 11 2014]
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sort by: Date | Relevance
FDA Announces "Purple Book" [Published Patent Docs - 19 hours ago]
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 ...
FDA Hosts Meeting to Put Pediatric Drug Develop... [Published FDA Law Blog - 23 hours ago]
By James E. Valentine* –On September 10, 2014, the FDA hosted its 3rd Annual Patient Network Meeting, “Under the Microscope: Pediatric Drug Development,” to explore challenges related to pediatric drug development.  The Patient Network is a program run ...
The “Purple Book” Makes Its Debut! [Published FDA Law Blog - Sep 09 2014]
By Kurt R. Karst –If you guessed that the cover of the publication listing biological products licensed under the Public Health Service Act (“PHS Act”), including licensed biosimilar and interchangeable biological products, would be “purple,” then you ...
FDA Establishes New "Purple Book" for Biosimilars [Published Future of BioPharma - Sep 09 2014]
It may not make the New York Times’ Best Seller List, but the release of the FDA’s new book is certainly noteworthy.  The FDA today announced that they’ve published their first ever edition of the “Purple Book”, a list of licensed biological products ...
FDA Looking for New Head of CDER Communications [Published Eye on FDA - Sep 02 2014]
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 ...
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