Center for Drug Evaluation and Research

Type: Organization
Name: Center for Drug Evaluation and Research
First reported Jul 24 2014 - Updated 13 hours ago - 1 reports

FDA approves a new painkiller

Share this article:The FDA has OK'd a new Purdue Pharma painkiller—Targiniq ER, which combines the prescription opioid oxycodone and overdose treatment naloxone. The Los Angeles Times explains that naloxone is in the mix to “block the euphoric effects ... [Published Medical Marketing And Media - Jul 24 2014]
First reported Jul 24 2014 - Updated Jul 24 2014 - 1 reports

Public Health News Roundup: July 24

FDA Approves New Oxycodone with Abuse-deterrent PropertiesThe U.S. Food and Drug Administration (FDA) has approved a new extended-release oxycodone with abuse-deterrent properties. Targiniq ER—which should be used to treat pain severe enough to require ... [Published RWJF - Jul 24 2014]
First reported Jul 23 2014 - Updated Jul 24 2014 - 1 reports

Doctors Warned Not To Use Compounded Drugs From Local Pharmacy

WASHINGTON (July 23, 2014) The U.S. Food and Drug Administration is warning doctors not to use compounded drugs from Unique Pharmaceuticals, a specialty pharmacy in Temple, because of risks of contamination.“Health care professionals should immediately ... [Published KWTX - Jul 23 2014]
First reported Jul 23 2014 - Updated Jul 24 2014 - 1 reports

Zydelig approved by FDA to treat three types of blood cancers

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced approval for Zydelig (idelalisib) to treat patients with three types of blood cancers.Traditional approval was granted to treat patients whose chronic lymphocytic leukemia has ... [Published Drug Store News - Jul 23 2014]
First reported Jul 23 2014 - Updated Jul 24 2014 - 1 reports

FDA clears Gilead's Zydelig for three types of leukaemia, lymphoma

The FDA said Wednesday that it approved Gilead Sciences' Zydelig (idelalisib) for three types of blood cancer, including use in combination with Roche's Rituxan (rituximab) for patients whose chronic lymphocytic leukaemia (CLL) has relapsed. The agency ... [Published FirstWord Pharma - Jul 23 2014]
First reported Jul 19 2014 - Updated Jul 19 2014 - 1 reports

US Federal Business Opportunity: Department of Health and Human Services: SEM Coupled Ramen System

Agency: Department of Health and Human ServicesOffice: Food and Drug Administration Location: Office of Acquisitions and Grants ServicesDate you need to respond by: 29-July-2014Solicitation Number: FDA-SOL-1130109 Naics code: 334516 Computer and Electronic ... [Published ITbriefing - Jul 19 2014]
First reported Jul 18 2014 - Updated Jul 18 2014 - 1 reports

21st Century Cures Initiatives Examines Care from A Patient’s Perspective

On July 11th, 2014, the House Energy and Commerce Health Subcommittee convened a hearing entitled "21st Century Cures: Incorporating the Patient Perspective". The hearing was part of the ongoing 21st Century Cures Initiative, a bipartisan effort to accelerate ... [Published HIMSS - Jul 18 2014]
First reported Jul 16 2014 - Updated Jul 16 2014 - 1 reports

FDA Releases Draft Guidance for IRBs, Clinical Investigators, and Sponsors on Informed Consent Information Sheet

Informed Consent Information SheetGuidance for IRBs, Clinical Investigators, and SponsorsDRAFT GUIDANCEAbout this Guidance DocumentThis draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's or Agency's) current thinking ... [Published Applied Clinical Trials - Jul 16 2014]
First reported Jul 14 2014 - Updated Jul 14 2014 - 1 reports

CDER Approvals In 2014

Article # 00140714007Posted: July 14 2014 12:01 AMExecutive SummaryFDA’s Center for Drug Evaluation and Research has approved 19 novel agents in 2014 to date: 13 new molecular entities and six therapeutic biologics. ... [Published Health News Daily - Jul 14 2014]
First reported Jul 14 2014 - Updated Jul 14 2014 - 1 reports

CBER Approvals In 2014

FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation and Research in 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins. ... [Published Health News Daily - Jul 14 2014]
First reported Jul 03 2014 - Updated Jul 04 2014 - 3 reports

FDA Approves Belinostat to Treat Rare Lymphoma

Earlier today the US Food and Drug Administration (FDA) granted accelerated approval to belinostat (Beleodaq) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and aggressive type of non-Hodgkin lymph ... [Published Cancernetwork.com - Jul 03 2014]
First reported Jun 26 2014 - Updated Jun 27 2014 - 2 reports

FDA Touts EHR Data Potential

This week, Janet Woodcock, MD – Director of Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) – penned a blog post discussing the potential of EHR data to help advance drug development and monitoring. Since electronic ... [Published HIMSS - Jun 26 2014]

Quotes

..."But it's remarkably nonquantitative for the most part," he said. "And I think we should try to think about whether there are quantitative ways of presenting that stuff."
...of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's CenterCenter for Drug Evaluation and Research, said in a statement. "Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain."
"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the publicpublic health crisis of prescription drugdrug abuse in the United States,” said Sharon Hertz, M D , deputy director of the division of anesthesia, analgesia and addiction products in the FDA’s Center for Drug Evaluation and Research. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”"
"If we really want to turn this epidemic around, the most important thing is to stop creating new cases of addiction" he told the Times. "Coming up with new gimmicks isn't going to help."

More Content

All (191) | News (174) | Reports (0) | Blogs (16) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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How Well Does A Drug Work? Look Beyond The Fine... [Published Boise State Public Radio - 15 hours ago]
FDA gives OK to Purdue Pharma's Targiniq ER [Published Chain Drug Review - 20 hours ago]
United States : FDA approves Zydelig for three ... [Published Pharmacy Choice - Jul 25 2014]
FDA Approves Zydelig To Treat Three Types Of Bl... [Published Black Press USA - Jul 25 2014]
FDA approves a new painkiller [Published Medical Marketing And Media - Jul 24 2014]
FDA Approves Idelalisib (Zydelig) for Three Typ... [Published Cancernetwork.com - Jul 24 2014]
‘Sterile’ Drug Products Recalled [Published P&T Community - Jul 24 2014]
FDA approves Targiniq ER from Purdue Pharma [Published Drug Store News - Jul 24 2014]
Purdue earns a nod--and a quick slap--for abuse... [Published FierceBiotech - Jul 24 2014]
FDA Approves Oxycodone with Abuse-deterrent Pro... [Published Pharmaceutical Manufacturing Magazine - Jul 24 2014]
Public Health News Roundup: July 24 [Published RWJF - Jul 24 2014]
US regulator clears Purdue's abuse-deterrent op... [Published FirstWord Pharma - Jul 24 2014]
FDA approves ER oxycodone formulation designed ... [Published Orthopedics Today - Jul 24 2014]
FDA Approves Indications for Zydelig for Three ... [Published Oncology Times - Jul 24 2014]
FDA Approves Abuse-Deterrent Oxycodone/Naloxone... [Published American Journal of Public Health - Jul 24 2014]
FDA approves abuse-deterrent painkiller [Published The Hill - Jul 23 2014]
Unique Pharmaceuticals Recalls All Sterile Drug... [Published Diabetes Care - Jul 23 2014]
FDA approves extended-release oxycodone with ab... [Published FOX6Now.com - Jul 23 2014]
FDA Announces Voluntary Recall of All Non-Expir... [Published Infection Control Today - Jul 23 2014]
FDA Approves Belinostat for Relapsed or Refract... [Published The ASCO Post - Jul 23 2014]
Doctors Warned Not To Use Compounded Drugs From... [Published KWTX - Jul 23 2014]
FDA announces voluntary nationwide recall of al... [Published Ein News - Jul 23 2014]
Zydelig approved by FDA to treat three types of... [Published Drug Store News - Jul 23 2014]
FDA clears Gilead's Zydelig for three types of ... [Published FirstWord Pharma - Jul 23 2014]
House GOP Demands FDA Explain Plaintiffs'-Lawye... [Published BusinessWeek - Jul 22 2014]
FDA approves Lymphoseek for head and neck cance... [Published Express Pharma - Jul 22 2014]
House GOP Demands FDA Explain Plaintiffs-Lawyer... [Published BusinessWeek - Jul 22 2014]
Novel Antibiotics for Skin and Soft Tissue Infe... [Published Diabetes Care - Jul 22 2014]
Amarin: Will The Lamb Of Ireland Bleat Or The L... [Published Seeking Alpha - Jul 21 2014]
Office of Generic Drugs updates key leadership ... [Published Drug Store News - Jul 21 2014]
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Blogs

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Want to Unlock the 21st Century Cure? Hearing W... [Published FDA Law Blog - Jul 16 2014]
By James E. Valentine* & Sara A. Khan** –On July 11, 2014, the House Energy and Commerce’s Subcommittee on Health held its fourth hearing, as part of its 21st Century Cures Initiative, to seek input regarding the incorporation of patient perspectives ...
Convention Attendees Make the Call on Expanded ... [Published I Am Biotech - Jun 24 2014]
The BIO International Convention kicked off Monday with an interactive session organized by the BIO Board Standing Committee on Bioethics: The Bioethics of Drug Development—You Make the Call . Attendees engaged in a real-time polling exercise addressing ...
As Senate and House Lawmakers Slog Through FDA ... [Published FDA Law Blog - May 29 2014]
By Kurt R. Karst –On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies ...
Big Door Keep Revolving - Our Latest Roundup Ab... [Published Health Care Renewal - May 22 2014]
The revolving door continues to turn connecting US government bodies that make health policy or regulate health care and the health care industry.  Sometimes these transitions are obvious, sometimes they are obscure.  The press sometimes makes the revolving ...
Minnesota Bans Widely Used (But Pretty Much Use... [Published The Consumerist - May 20 2014]
( Clean Walmart ) In spite of the fact that the FDA has said that soap containing the antibacterial chemical triclosan is really no better at preventing the spread of germs than simply washing your hands with regular hot soap and water , it’s still ...
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