FDA Food & Drug Administration

Type: Organization
Name: FDA Food & Drug Administration (Food and Drug Administration, FDA, Federal Drug Administration)
First reported 20 hours ago - Updated 4 mins ago - 18 reports

Burgess Expresses Concern with FDA Guidance on Laboratory Developed Tests (LDTs)

Congressman Michael C. Burgess, M.D. (R-TX), vice chairman of the House Energy and Commerce Subcommittee on Health, today responded to the Food and Drug Administration's (FDA) notification to Congress that it will release draft guidance to regulate laboratory ... [Published Noodls - 4 mins ago]
First reported 17 hours ago - Updated 1 hour ago - 11 reports

FDA Approves Striverdi Respimat to Treat Chronic Obstructive Pulmonary Disease

-- Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are... ... [Published Drugs.com - 1 hour ago]
First reported Jul 31 2014 - Updated 4 hours ago - 3 reports

New U.S. FDA Medical Device User Fees for FY 2015

The U.S. FDA released medical device user fee rates and payment procedures for FY 2015. Registrar Corp explains the fees and payment process to the industry. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the U.S. Food and Drug Administration ... [Published PRWeb - 4 hours ago]
First reported 18 hours ago - Updated 9 hours ago - 5 reports

FDA to Begin Regulating Laboratory Test Devices

(The Washington Post) – The Food and Drug Administration announced Thursday plans to begin regulating certain diagnostic tests developed by laboratories, which have both proliferated and grown more sophisticated in recent years, spurring increa...Related ... [Published BioPortfolio - 9 hours ago]
First reported 17 hours ago - Updated 12 hours ago - 8 reports

Baxter’s HyQvia Rises Above FDA’s Theoretical Long-Term Concerns

Related Biotechnology, Pharmaceutical and Healthcare NewsAgency officials say long-term immunogenicity issues could manifest among patients taking proposed primary immunodeficiency disorder treatment, but advisory committee concludes risk can be mana ... [Published BioPortfolio - 12 hours ago]
First reported Jul 31 2014 - Updated 12 hours ago - 5 reports

U.S. FDA Cites Problems With Cadila Drug-Production Plant In India

Related Biotechnology, Pharmaceutical and Healthcare NewsThe U.S. FDA has questioned drug-production processes at yet another India plant, this one operated by Cadila Healthcare.Original Article: NEXT ARTICLE More From BioPortfolio on "U.S. FDA Cites ... [Published BioPortfolio - 12 hours ago]
First reported Jul 31 2014 - Updated 13 hours ago - 6 reports

Consumer Reports: FDA Should Make Painkillers Safer

iStock/Thinkstock (NEW YORK) -- Consumer Reports is calling on the Food and Drug Administration to make painkillers safer.According to Consumer Reports , every day, 46 people die and more than 1,000 go to emergency rooms because they're taking legal drugs ... [Published KMBZ - 13 hours ago]
First reported Jul 30 2014 - Updated 14 hours ago - 12 reports

J&J withdraws controversial uterine fibroid removal device from the market

(Reuters) - Johnson & Johnson said on Wednesday it plans to ask doctors to return its power morcellators, a controversial surgical device that may inadvertently spread cancer in women being treated for uterine growths called fibroids.J&J's Ethicon unit ... [Published MedCity News - 14 hours ago]
First reported 23 hours ago - Updated 14 hours ago - 4 reports

USFDA raises concern over Cadila Healthcare plant

Pharmaceuticals company Cadila Healthcare appears to be the latestfirm this year to fall under the USFDA scanner, this time red flaggedfor Form 483 on one of their products manufactured at the Moraiyaplant in Gujarat.“The form 483 we received was for ... [Published Financial Chronicle - 14 hours ago]
First reported Jul 30 2014 - Updated 14 hours ago - 4 reports

Despite promising progress, the US trails Europe in facilitating novel antibiotics development

While the Generating Antibiotic Incentives Now (GAIN) Act of 2012 has been a significant step in the right direction for encouraging novel antibiotics research, the US FDA remains one step behind its European equivalent, the European Medicines Agency ... [Published European Pharmaceutical Manufacturer - 17 hours ago]
First reported Jul 30 2014 - Updated 17 hours ago - 5 reports

FDA panel recommends against approval of ultrasound therapy for early prostate cancer

GAITHERSBURG, MD. – A Food and Drug Administration advisory panel agreed that a device that thermally ablates the prostate gland using high-intensity focused ultrasound should not be approved for... ... [Published Oncology Report - 17 hours ago]
First reported Jul 30 2014 - Updated Jul 30 2014 - 11 reports

Regeneron's Eylea Gets FDA Nod for Diabetic Macular Edema

Regeneron Pharmaceuticals, Inc. ’s ( REGN - Analyst Report ) eye drug Eylea received FDA approval for a third indication − the treatment of diabetic macular edema (DME).Eylea is already approved for the treatment of neovascular age-related macular degeneration ... [Published Zacks.com - Jul 30 2014]

Quotes

"Even if this particular drug does not succeed through the whole drug approval process, we can use it to construct a new drug for this deadly disease."
...on the CIA Inspector General report today, I have no choice but to call for the resignation of CIA Director John Brennan," he said in a statement. "The CIA unconstitutionally spied on Congress by hacking into Senate Intelligence Committee computers. This grave misconduct not only is illegal, but it violates the U S Constitution’s requirement of separation of powers. These offenses, along with other errors in judgment by some at the CIA, demonstrate a tremendous failure of leadership, and there must be consequences."
Perrigo's chairman president and chiefchief executive officer, Joseph C Papa stated, "This filing highlights our continued investment in new products and dedication to bringing topicals to market. Perrigo is committed to making quality healthcare more affordable for consumers around the globe."
...D R Rao , Chairman and Managing Director of Neuland Labs . "We are now back to our regular schedule and expect to achieve the planned growth in revenues and profits for the year."

More Content

All (22362) | News (18568) | Reports (3) | Blogs (3452) | Audio/Video (4) | Fact Sheets (39) | Press Releases (215)
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Burgess Expresses Concern with FDA Guidance on ... [Published Noodls - 4 mins ago]
Pure Garcinia Cambogia Extract - Starting up a ... [Published Amersham People - 5 mins ago]
Bitter Kola to the rescue? - Scientists reveal ... [Published Joy FM - 6 mins ago]
Abbreviated Pundit Round-up: The politics and e... [Published Daily Kos - 6 mins ago]
Perrigo confirms first to file patent challenge... [Published PharmaBiz - 7 mins ago]
Global Protein Ingredient Market Size 2014 Indu... [Published CW Atlanta - 11 mins ago]
Neuland Labs Reports First Quarter Fiscal Year ... [Published Barchart - 18 mins ago]
oxycodone, Oxycontin, Roxicodone, Oxect [Published MedicineNet.com - 25 mins ago]
Joshua Sharfstein exit puts Department of Healt... [Published Business First of Buffalo - 26 mins ago]
KuicK Research: Transdermal Drug Delivery Marke... [Published BusinessWeek - 38 mins ago]
Confronting the most aggressive, evasive, and c... [Published Medical Xpress - 40 mins ago]
Isis Pharmaceuticals Initiates Phase 3 Study of... [Published Michigan Live - 45 mins ago]
Banned e-cigarettes recovered from Gurgaon [Published ProKerala.com - 53 mins ago]
Need to Shun Age-old Methods [Published EGov Online - 1 hour ago]
Sheriff presents resolution opposing the legali... [Published The Cross Timbers Gazette - 1 hour ago]
FDA Approves Striverdi Respimat to Treat Chroni... [Published Drugs.com - 1 hour ago]
Boehringer’s Striverdi gains FDA approval [Published Pharmafocus - 1 hour ago]
Johnson & Johnson Withdraw Device Linked to Spr... [Published The Utah People's Post - 1 hour ago]
CEO Reasserts Control Over Biotech Developer of... [Published BusinessWeek - 1 hour ago]
LabStyle receives approval to sell Dario smart ... [Published PharmaBiz - 2 hours ago]
UPSC CSAT row: Govt. to give decision on Varma ... [Published Topnews.in - 2 hours ago]
Youth Congress stages protest against ex-minist... [Published Topnews.in - 2 hours ago]
Food poisons more than 170, fast-food company o... [Published Ecns.cn - 2 hours ago]
The Sugar Association Calls For Withdrawal of ‘... [Published Noodls - 2 hours ago]
Top stories in health and medicine, August 1, 2014 [Published BioPortfolio - 2 hours ago]
UBE : Further Analyses Confirms Alaska Seafood ... [Published 4 Traders - 2 hours ago]
Assoc Dir, Clinical Ops [Published PharmaDiversity - 2 hours ago]
Array BioPharma (ARRY) Orphan Drug Status for O... [Published Live-PR.com - 2 hours ago]
SPARC posts net loss of Rs. 10 crore in Q1 [Published PharmaBiz - 2 hours ago]
Gil Van Bokkelen: Japan's leadership in regener... [Published Nikkei Asian Review - 3 hours ago]
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Blogs

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Medical labs to get new FDA oversight [Published Greenspace - 9 hours ago]
The Food & Drug Administration on Thursday announced it would step up its regulation of a class of lab tests that have been key in ushering in an era of personalized medicine -- a step the agency has long considered against strong opposition by small ...
The Association for Molecular Pathology Voices ... [Published Business Wire Health News - 11 hours ago]
BETHESDA, Md.--(BUSINESS WIRE)--The Association for Molecular Pathology reaffirmed its position that the vast majority of laboratory developed procedures should continue operating under the regulation of the CLIA program at the CMS ...
Court: It's Only Unconstitutional If You, Not W... [Published Drug and Device Law - 15 hours ago]
A bit of a rant today. We’ve just read Gibson v. American Cyanamid Co., ___ F.3d ___, 2014 WL 3643353 (7th Cir. July 24, 2014), and we have to say that it’s one of the most constitutionally arrogant decisions we’ve ever read.  Stripped to its essentials, ...
Toward More Comprehensive Food Labeling [Published NEJM Articles Most Widely Covered in the Press - 16 hours ago]
The Food and Drug Administration (FDA) is proposing to revise the Nutrition Facts label that must appear on virtually all packaged foods in the United States. The agency's proposals are strong, urgently needed, and likely to make an important contribution ...
ACLA Expresses Concern with FDA Guidance on Lab... [Published PR Newswire: Policy & Public Interest - 17 hours ago]
WASHINGTON, July 31, 2014 /PRNewswire-USNewswire/ -- In response to today's announcement that the Food and Drug Administration (FDA) will release a draft guidance in 60 days to regulate laboratory developed tests (LDTs), the American Clinical Laboratory ...
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Audio/Video

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Is Siberia a Safe Place for Smallpox? [Published Slate Magazine - Jul 15 2014]
The Persistent Danger of Poxes [Published Slate Magazine - Jul 11 2014]
FDA Reviewing Psychiatric Side Effects of Chantix [Published Wall Street Journal What's News - Apr 25 2014]
New at-home colon cancer test shows promising r... [Published Reuters Video: Top News - Mar 19 2014]
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Press Releases

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Complete Response Letter from FDA, Positive Opi... [Published Financial Services - 22 hours ago]
K2M Continues Momentum with Complex Spine & Min... [Published GlobeNewswire: Acquisitions News - Jul 31 2014]
EDAP Updates on FDA Advisory Committee Meeting ... [Published GlobeNewswire: Acquisitions News - Jul 30 2014]
Sanofi and Regeneron Announce Plan to Use Prior... [Published Sanofi.com - Last press releases - Jul 30 2014]
Diplomat receives distribution contract for Zyd... [Published Financial Services - Jul 28 2014]
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