Center for Drug Evaluation and Research

Type: Organization
Name: Center for Drug Evaluation and Research
First reported 14 hours ago - Updated 12 hours ago - 1 reports

FDA approves new labeling for extended-release Embeda

The FDA has approved new labeling for an extended-release pain relief combination of morphine sulfate and naltrexone hydrochloride that includes information on potential abuse deterrent properties.According to a press release from the FDA, the drug combination ... [Published Orthopedics Today - 14 hours ago]
First reported 14 hours ago - Updated 14 hours ago - 1 reports

FDA Approves Two Drugs for IPF

The U.S. FDA approved both Ofev and Esbriet for treating idiopathic pulmonary fibrosis (IPF).Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of ... [Published Pharmaceutical Manufacturing Magazine - 14 hours ago]
First reported Oct 17 2014 - Updated Oct 17 2014 - 1 reports

Dupuytren's Contracture

Treatment Option FDA Approves Xiaflex for Debilitating Hand ConditionThe U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, ... [Published MedicineNet.com - Oct 17 2014]
First reported Oct 15 2014 - Updated Oct 16 2014 - 3 reports

FDA approves two new drugs to treat IPF

SILVER SPRING, Md. — The Food and Drug Administration has granted approval to Esbriet (pirfenidone), as well as Ofev (nintedanib), to treat idiopathic pulmonary fibrosis — a condition in which the lungs scar over time. As a result of the scarring, patients ... [Published Drug Store News - Oct 16 2014]
First reported Oct 15 2014 - Updated Oct 15 2014 - 1 reports

FDA Releases Draft Guidance for Industry on Meetings to Improve Drug Development

body: FDA is releasing a draft guidance for industry on critical path innovation meetings (CPIMs) that aim to improve efficiency and success in drug development. CPIMs enable FDA's Center for Drug Evaluation and Research and investigators from industry, ... [Published AAPS Pharmceutica - Oct 15 2014]
First reported Oct 15 2014 - Updated Oct 15 2014 - 1 reports

Drugs seized here to be destroyed

A federal court in Cincinnati last week issued a consent decree for a permanent injunction against a New Jersey company for releasing unapproved drugs. The drugs were seized by federal marhsals in May 2014 at a Cincinnati area warehouse operated by Masters ... [Published Cincinnati.com - Oct 15 2014]
First reported Oct 13 2014 - Updated Oct 13 2014 - 1 reports

New nausea relief for chemo patients approved

The FDA has given its seal of approval to Akynzeo (netupitant and palonosetron), a “fixed” combination capsule comprised of Oral palonosetron and Netupitant to treat nausea and vomiting in patients undergoing cancer chemotherapy .“Supportive care products, ... [Published Examiner.com - Oct 13 2014]
First reported Oct 13 2014 - Updated Oct 13 2014 - 1 reports

FDA approves Bracco's ultrasound contrast agent

Bracco Diagnostics Inc. announced on Friday that its ultrasound contrast agent — Lumason — received approval from the FDA. It's used for patients whose echocardiograms are difficult to view with ultrasound waves.The agent is comprised of gas-filled microbubbles ... [Published Dotmed - Oct 13 2014]
First reported Oct 11 2014 - Updated Oct 11 2014 - 3 reports

New Hepatitis C Pill Promises Faster Treatment, At A Higher Cost

The FDA has approved a once-a-day pill that combines two drugs to treat hepatitis C, the deadly virus that attacks the liver and is believed to infect 3.2 million Americans. The new product brings several advances, but it also has a steep price tag, reported ... [Published WNYC - Oct 11 2014]
First reported Oct 10 2014 - Updated Oct 11 2014 - 2 reports

FDA approves new agent for contrast-enhanced echocardiograms

The FDA has approved sulfur hexafluoride lipid microsphere as a contrast agent for patients undergoing echocardiograms.According to a press release, sulfur hexaflouoride lipid microsphere, or Lumason (Bracco Diagnostics Inc.), consists of gas-filled microbubbles ... [Published Orthopedics Today - Oct 11 2014]
First reported Oct 08 2014 - Updated Oct 08 2014 - 1 reports

Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen; Draft Guidance for Industry; Availability

ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, ... [Published Insurance News Net - Oct 08 2014]
First reported Oct 02 2014 - Updated Oct 02 2014 - 1 reports

10 things that would fix the food system faster than GMO-labeling

If we want a better food system there are plenty of things that would make a bigger difference than GMO labeling. The other day I argued that labeling probably wouldn’t have an effect on the big picture issues that people attach to GMOs. Here are ... [Published Grist - the Latest from Grist - Oct 02 2014]

Quotes

Williams told Sapa: "Approximately 3,000 South African patients who suffer from multidrug-resistant tuberculosis will now be able to receive Bedaquiline. A total of 6,000 patients are expected to be treated in the second year."
"Before the FDA approved Xiaflex, the only effective treatment for this hand disorder was surgery, which sometimes meant a long recovery and the need for physical therapy for patients. Since there are no other non-surgical alternatives for Dupuytren's contracture, Xiaflex will be an important advance in the management of this disabling condition" said Bob Rappaport, M D , director, Division of Anesthesiology, Analgesia, and Rheumatology of the FDA's CenterCenter for Drug Evaluation and Resear...
...deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, added that Ofev's approval will provide "healthcare professionals and patients with additional treatment options that helps enable appropriate care decisions based on a patient’s need.”"
"If e-cigarettes... are thoughtfully regulated, they could play the same role as NRT, but at a truly national population scale. Their use could shift smokers permanently away from lethal cigarettes to cleaner, safer nicotine products, saving innumerable lives" they conclude...

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All (162) | News (143) | Reports (0) | Blogs (19) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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New TB drug, but still barriers to treatment [Published NOW! - 59 mins ago]
FDA approves new labeling for extended-release ... [Published Orthopedics Today - 14 hours ago]
FDA Approves Two Drugs for IPF [Published Pharmaceutical Manufacturing Magazine - 14 hours ago]
Ondansetron for the Treatment of IBS With Diarrhea [Published General Medicine eJournal - Oct 20 2014]
FDA Approves Label for Embeda to Deter Abuse [Published The Guardian Express - Oct 18 2014]
New CDER “Super Office” to Promote Drug Quality [Published Pharmaceutical Executive - Oct 17 2014]
Dupuytren's Contracture [Published MedicineNet.com - Oct 17 2014]
Umeclidinium/Vilanterol and Umeclidinium in COPD [Published General Medicine eJournal - Oct 17 2014]
FDA approves two new drugs to treat IPF [Published Drug Store News - Oct 16 2014]
US FDA approves Genentech’s Esbriet and Boehrin... [Published Pharma Letter - Oct 16 2014]
CDER Creates "Super-Office" to Keep Closer Eye ... [Published Genetic Engineering News - Oct 16 2014]
FDA Approves Two Drugs to Treat Idiopathic Pulm... [Published RT Magazine - Oct 16 2014]
The FDA, E-Cigarettes, and the Demise of Combus... [Published New England Journal of Medicine - Oct 16 2014]
FDA Approves Two Drugs for Idiopathic Pulmonary... [Published General Medicine eJournal - Oct 15 2014]
NEJM Perspective: 'The FDA, e-cigarettes, and t... [Published EurekAlert! - Oct 15 2014]
'The FDA, e-cigarettes, and the demise of combu... [Published Medical Xpress - Oct 15 2014]
FDA Releases Draft Guidance for Industry on Mee... [Published AAPS Pharmceutica - Oct 15 2014]
FDA approves Ofev to treat idiopathic pulmonary... [Published Ein News - Oct 15 2014]
FDA approves Esbriet to treat idiopathic pulmon... [Published Ein News - Oct 15 2014]
Psychiatric Drug Combination Approved for Weigh... [Published Psychiatric News - Oct 15 2014]
Drugs seized here to be destroyed [Published Cincinnati.com - Oct 15 2014]
A Review Of Gilead's Harvoni, And Competitive C... [Published Seeking Alpha - Oct 15 2014]
Alkem Labs arm banned from manufacturing, selli... [Published Business Standard India - Oct 15 2014]
Federal judge approves FDA consent decree with ... [Published Ein News - Oct 14 2014]
New nausea relief for chemo patients approved [Published Examiner.com - Oct 13 2014]
FDA approves Bracco's ultrasound contrast agent [Published Dotmed - Oct 13 2014]
Ultrasound Contrast Agent Market Grows with FDA... [Published Diagnostic Imaging - Oct 13 2014]
FDA gives nod to Bracco Diagnostics' Lumason fo... [Published FierceMedicalDevices - Oct 13 2014]
Eisai wins approval for chemotherapy side effec... [Published PMLive - Oct 13 2014]
UPDATED: Gilead gets FDA okay for HCV combo pill [Published Pharma Times - Oct 12 2014]
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10 things that would fix the food system faster... [Published Grist - the Latest from Grist - Oct 02 2014]
If we want a better food system there are plenty of things that would make a bigger difference than GMO labeling. The other day I argued that labeling probably wouldn’t have an effect on the big picture issues that people attach to GMOs. Here are ...
Bilirakis Questions FDA About Biomarkers [Published Rep. Gus Bilirakis - YouTube Channel - Sep 30 2014]
<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. ...
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