Center for Drug Evaluation and Research

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

Annual DRI Shameless Plug

Here is our annual publicity stunt for the Defense Research Institute’s Drug and Device Seminar: *************Please join us at the 2014 DRI Drug & Device Seminar May 15 – 16, 2014 at the Renaissance Downtown Hotel in Washington, D.C. The program includes:•           ... [Published Drug and Device Law - 14 hours ago]
First reported Apr 17 2014 - Updated 22 hours ago - 1 reports

FDA Approves New Type 2 Diabetes Drug

body: Millions of Americans with Type 2 diabetes have a new treatment option with the U.S. Food and Drug Administration's approval of a once-weekly injectable drug, Tanzeum. The FDA described Tanzeum (albiglutide) as a "glucagon-like peptide-1 (GLP-1) ... [Published AAPS Pharmceutica - Apr 17 2014]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

New Type 2 Diabetes Treatment Approved

The FDA has approved Tanzeum subcutaneous injection for those living with type 2 diabetes. FDA is requiring post-marketing studies for Tanzeum, including a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients.Apr 16, 2014The FDA ... [Published Occupational Health & Safety - Apr 16 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 1 reports

FDA Issues Notice about Opioid Analgesics Misuse and Abuse

WASHINGTON, April 10 -- Food and Drug Administration has issued a notice called: Center for Drug Evaluation and Research; Use of Innovative Packaging, Storage, and/or Disposal Systems To Address the Misuse and Abuse of Opioid Analgesics; Request for Comments; ... [Published HighBeam Research - Apr 11 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 1 reports

Weekly Roundup 4.11.14

A few weeks ago it was snowing.  Today, a walk around the neighborhood yields views of piles of mulch near driveways ready to be loaded into wheelbarrows and spread into the garden beds.  Bags of topsoil are lined up.  Grass seed is nearby and already ... [Published Eye on FDA - Apr 11 2014]
First reported Apr 09 2014 - Updated Apr 09 2014 - 1 reports

How I Lead: Listen, Breathe and Then Ask Questions

Melanie Keller is associate director for management at the Center for Drug Evaluation and Research, the largest center at the Food and Drug Administration. As the executive officer, she oversees administrative operations and a $1 billion annual budget. ... [Published Government Executive - Apr 09 2014]
First reported Apr 09 2014 - Updated Apr 09 2014 - 1 reports

Draft Guidance for Industry on Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for New Drug Applications and...

Draft Guidance for Industry on Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for New Drug Applications and Abbreviated New Drug Applications; AvailabilityNotice.Citation: "79 FR 19621"Document Number: "Docket No. ... [Published Pharmacy Choice - Apr 09 2014]
First reported Apr 07 2014 - Updated Apr 08 2014 - 1 reports

Senate Dems want crackdown on e-cigs

Half a dozen Senate Democrats called Monday on a pair of federal agencies to go after electronic cigarette companies that claim their wares can help smokers quit.The Food and Drug Administration (FDA) is readying regulations that would bring the burgeoning ... [Published The Hill - Apr 07 2014]
First reported Apr 08 2014 - Updated Apr 08 2014 - 1 reports

FDA examining new rules and studies regarding sunscreen safety

The tremendous increase in sunscreen use over the last generation has created a need to reevaluate the safety of its ingredients. So Congress was told by an official of the Food & Drug Administration (FDA) on Monday, April 7.Janet Woodcock, director ... [Published Examiner.com - Apr 08 2014]
First reported Apr 07 2014 - Updated Apr 07 2014 - 1 reports

Living Well: FDA approves pocket protector

A pocket-sized injection device that can deliver medicine to reverse the effects of prescription drug and heroin overdose won fast-track approval from the Food and Drug Administration last week.The EpiPen-like “Evizio” provides a single doze of the drug ... [Published News-Press.com - Apr 07 2014]
First reported Apr 04 2014 - Updated Apr 05 2014 - 2 reports

Va. firm wins FDA approval for overdose treatment

RICHMOND, Va. — A Richmond-based company has received federal approval for a drug treatment that reverses the effects of pain medicine or heroin overdose.According to the Richmond Times-Dispatch (http://bit.ly/1lFCyom ), the U.S. Food and Drug Administration ... [Published Kentucky.com - Apr 04 2014]
First reported Mar 31 2014 - Updated Apr 01 2014 - 1 reports

Week ahead: O-Care enrollment deadline arrives

ObamaCare’s first enrollment period officially comes to a close on Monday, and all eyes will be on the administration to see how many people signed up for coverage in the law’s first year.The White House met its own target last week when officials announced ... [Published The Hill - Mar 31 2014]

Quotes

"Because the guidance document should be written for industry personnel of all experience levels, the examples used in the final guidance should be as clear and concise as possible" CHPA stated
According to a press release on the FDA web site, "Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet." It's given to a person one of two ways: either injected subcutaneously (under the skin) or intramuscularly (directly in the muscle)
...The FDA described Tanzeum (albiglutide) as a "glucagon-like peptide-1 (GLP-1) receptor agonist — a hormone that helps normalize patients' blood sugar levels. Tanzeum "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's CenterCenter for Drug Evaluation and Research, said in an agency news release."
"Tanzeum is a new treatment option for the millions of Americans living with type II diabetes" said Curtis Rosebraugh, Director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research...

More Content

All (231) | News (214) | Reports (0) | Blogs (14) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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CRN: FDA's IND Guidance Could Harm Supplement I... [Published Natural Products Industry Insider - 5 hours ago]
Annual DRI Shameless Plug [Published Drug and Device Law - 14 hours ago]
FDA approves portable device to reverse opioid ... [Published Natural News - 20 hours ago]
FDA Approves New Type 2 Diabetes Drug [Published AAPS Pharmceutica - Apr 17 2014]
US FDA approves Tanzeum to treat type II diabetes [Published Express Pharma - Apr 16 2014]
FDA approves new drug for people with type 2 di... [Published Nurse.com - Apr 16 2014]
FDA finally OKs GlaxoSmithKline’s Tanzeum to tr... [Published Pharma Letter - Apr 16 2014]
FDA approves GSK's Tanzeum for type 2 diabetes [Published Bio Spectrum Asia - Apr 16 2014]
New Type 2 Diabetes Treatment Approved [Published Occupational Health & Safety - Apr 16 2014]
“Rescue Pen” Averts Opioid Overdose Risk [Published Hospi Medica - Apr 16 2014]
FDA wants pharma to move from compliance to qua... [Published Packaging World - Apr 16 2014]
FDA approves once a week diabetes injection: Co... [Published EMax Health - Apr 16 2014]
FDA Approves New Type 2 Diabetes Drug-April 15,... [Published InteliHealth - Apr 15 2014]
FBR : Sources Sought Notice - Upgrade Thermo Sc... [Published 4 Traders - Apr 15 2014]
FDA Approves Weekly Injectable Albiglutide (Tan... [Published Dermatology Online Journal - Apr 15 2014]
APhA seeks consistency in generics labeling [Published Pharmacist.com - Apr 15 2014]
FDA approves Tanzeum to improve glycemic contro... [Published Orthopedics Today - Apr 15 2014]
Tanzeum granted FDA approval [Published Drug Store News - Apr 15 2014]
FDA clears GlaxoSmithKline's diabetes therapy T... [Published FirstWord Pharma - Apr 15 2014]
FDA approves Tanzeum to treat type 2 diabetes [Published U.S. Food and Drug Administration - Apr 15 2014]
No Legwork Mondays – Merck And Vioxx [Published Benzinga.com - Apr 14 2014]
Hidden drugs found in Zi Xiu Tang bee pollen po... [Published Examiner.com - Apr 13 2014]
E-cigs on rise; smokers tout vapor as beneficial [Published Laurinburg Exchange - Apr 12 2014]
Ezra Klein Headlines the PRSA 2014 Health Acade... [Published PRSA NewsRoom - Apr 12 2014]
FDA Issues Notice about Opioid Analgesics Misus... [Published HighBeam Research - Apr 11 2014]
Weekly Roundup 4.11.14 [Published Eye on FDA - Apr 11 2014]
States don’t wait for feds on e-cigarette restr... [Published Washington Post - Apr 10 2014]
Dose Response of Umeclidinium 1-2x Daily in COPD [Published General Medicine eJournal - Apr 10 2014]
Shaw T. Chen, M.D., Ph.D. joins Polaris [Published HispanicBusiness.com - Apr 10 2014]
FDA’s Role in Disaster Preparedness: Q&A with B... [Published RWJF - Apr 10 2014]
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sort by: Date | Relevance
Annual DRI Shameless Plug [Published Drug and Device Law - 14 hours ago]
Here is our annual publicity stunt for the Defense Research Institute’s Drug and Device Seminar: *************Please join us at the 2014 DRI Drug & Device Seminar May 15 – 16, 2014 at the Renaissance Downtown Hotel in Washington, D.C. The program includes:•           ...
Weekly Roundup 4.11.14 [Published Eye on FDA - Apr 11 2014]
A few weeks ago it was snowing.  Today, a walk around the neighborhood yields views of piles of mulch near driveways ready to be loaded into wheelbarrows and spread into the garden beds.  Bags of topsoil are lined up.  Grass seed is nearby and already ...
FDA Expands Access to Overdose Antidote to Stem... [Published TIME.com - Apr 03 2014]
The Food and Drug Administration (FDA) has approved the first auto-injecting version of Naloxone as part of the government’s efforts to control the epidemic of opiate addiction and overdoses from narcotic drugs, which include prescription medications ...
Still Burned by the FDA [Published Marginal Revolution - Mar 21 2014]
Excellent piece in the Washington Post on the FDA and sunscreen: …American beachgoers will have to make do with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade. That’s ...
Director of FDA’s Center for Drug Evaluation an... [Published Business Wire Health News - Mar 17 2014]
HORSHAM, Pa.--(BUSINESS WIRE)--Director of FDA’s Center for Drug Evaluation and Research to Introduce New Office of Pharmaceutical Quality at DIA Annual Meeting ...
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