FDA Food & Drug Administration

Type: Organization
Name: FDA Food & Drug Administration (Food and Drug Administration, FDA, Federal Drug Administration)
First reported 19 hours ago - Updated 1 hour ago - 6 reports

Department Of Homeland Security Investigates Medical Device Cybersecurity Flaws

By , Ph.D.The Department of Homeland Security (DHS) is currently investigating dozens of cybersecurity cases related to medical devices and their potential for exploitation. The focus is on finding and rectifying vulnerabilities.As medical devices have ... [Published Medical Design Online - 1 hour ago]
First reported 18 hours ago - Updated 2 hours ago - 12 reports

Baxter Announces FDA Approval For New Hemophilia Drug

Baxter International Inc. announced that the United States Food and Drug Administration (FDA) has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), ... [Published Drug Discovery and Development - 10 hours ago]
First reported 18 hours ago - Updated 7 hours ago - 4 reports

Harkin Marks 20th Anniversary of DSHEA

Senator Tom Harkin (D-IA) released the following statement marking the 20th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA) this week. The law, championed by Harkin and Senator Orin Hatch (R-UT), aimed to help the Food and ... [Published Nutraceuticals World - 7 hours ago]
First reported Oct 23 2014 - Updated 8 hours ago - 6 reports

Uni-President joins casualty list

Uni-President Enterprise Corp (統一企業), the nation’s largest food manufacturer, yesterday became engulfed in the nation’s latest cooking oil scandal, with 19 of its beef-based products ordered off the shelves, the Food and Drug Administration (FDA) sai ... [Published Taipei Times Online - 8 hours ago]
First reported 14 hours ago - Updated 8 hours ago - 2 reports

FDA launches seafood labeling-compliance module

Published on 24 October, 2014The U.S. Food and Drug Administration (FDA) on Thursday launched an online tool to help seafood retailers, processors and regulators comply with federal labeling laws.The Fish and Fishery Products Hazards and Controls Guidance ... [Published SeafoodSource.com - 8 hours ago]
First reported 17 hours ago - Updated 11 hours ago - 4 reports

FDA Approves New Hemophilia A Drug, Obizur

The Food and Drug Administration Thursday approved Obizur for the treatment of adults with acquired hemophilia A, a very rare and potentially life-threatening bleeding disorder that affects both men and women. Drug maker Baxter International evaluated ... [Published Medical Daily - 11 hours ago]
First reported Oct 24 2014 - Updated 14 hours ago - 5 reports

Long-Awaited FDA Report on LASIK Confirms Safety and Effectiveness, with High Rates of Patient Satisfaction

Chicago, IL, October 24, 2014 --( PR.com )-- Results reported by the Food & Drug Administration (FDA) on a long-awaited comprehensive prospective, multi-center study on the safety and efficacy of LASIK were well-received by refractive surgeons in attendance ... [Published PR.com Press Releases - 14 hours ago]
First reported Oct 23 2014 - Updated 15 hours ago - 8 reports

FDA Postpones Its Final Decision On Point Lookout's Natpara

October 24, 2014By Jessica Wilson , BioSpace.com Breaking News StaffNPS Pharmaceuticals, Inc. ( NPSP ) today announced that the U.S. Food and Drug Administration (FDA) has extended the company’s Prescription Drug User Fee Act ( PDUFA ) action date for ... [Published BioSpace - 15 hours ago]
First reported Oct 24 2014 - Updated 17 hours ago - 14 reports

Market report: Hikma gets a painful lesson in FDA’s ability to make or break

For today at least, it seems the drugs don’t work for investors.Hikma Pharmaceuticals tumbled to the bottom of the mid-cap index after the Jordanian generic drug maker admitted it has received a warning letter from the US Food and Drug Administration ... [Published NewsRT.co.uk - 17 hours ago]
First reported Oct 23 2014 - Updated Oct 24 2014 - 8 reports

Feds warn against decorative contact lenses

NEWSVision can be permanently damaged by wearing lenses without prescriptionPosted TODAY, 9:25 PM Updated TODAY, 9:25 PMSAN ANTONIO - If you’re buying decorative contact lenses without a prescription, you could do serious damage to your eyes.RELATED ... [Published KSAT 12 - Oct 24 2014]
First reported Oct 23 2014 - Updated Oct 23 2014 - 5 reports

Drug-tainted supplements still available for purchase, study finds

Hundreds of dietary supplements containing illegal drugs have been voluntarily recalled from the market in recent years at the urging of the U.S. Food and Drug Administration, but a significant number have remained available for purchase with their same ... [Published Harvard Medical School - Oct 23 2014]
First reported Oct 23 2014 - Updated Oct 23 2014 - 4 reports

One Year after Data Breach, FDA System Still Vulnerable

The OIG revealed that the FDA’s computer network is vulnerable to a potential data breach. A recent audit by the Office of the Inspector General (OIG) revealed that the Food and Drug Administration’s (FD) computer network is vulnerable to a potential ... [Published Health IT Security - Oct 23 2014]

Quotes

" Oxygenated myoglobin is red, but when its structure is changed by heat or by other molecules, it changes color. That's why redness in cooked meat signifies juiciness: As meat cooks, the heat causes the other meat proteins to coagulate and squeeze out their moisture."
"Hospira has implemented software adjustments, distributed customer communications and made a commitment to evaluate other changes going forward, while ensuring we are not adversely impacting the ability of our devices to meet hospital and patient needs, and maintain compliance with FDA product requirements" Tareta Adams, spokesperson for Hospira, said in a statement cited by Reuters
Dr. Craig Dees , PhD, CEO of Provectus, said, "Provectus is pleased to be working with INC Research Quality and Compliance Consulting in conducting this audit. By retaining their services, we are endeavoring to ensure that the upcoming phase 3 trial for PV-10 as a treatment for melanoma as well as the future tests of both PV- 10 for other indications and for PH-10 to treat dermatological diseases proceed with all possible speed. Making sure that all the paperwork is available and in good order will smooth out the process."
Vincent Gardes , Vexim's CEO, stated: "Our discussions with the FDA have enabled us to make meaningful progress toward driving Vexim's future growth and development, as it relates to targeting the United States , which is the world's largest market for vertebroplasty and kyphoplasty. Based on the excellent results obtained in clinical studies to date with SpineJack, particularly as evidenced by the 30 patients suffering from osteoporosis whose success we recently reported, we are fully confident in achieving a positive outcome from this new study, which once completed, will support our application for clearance to market our device in the U S Furthermore, the fact that we will follow a 510(k) pathway, rather than PMA, combined with the possibility of only conducting the study in Europe , makes its timetable and cost very attractive for Vexim ."

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All (14805) | News (13450) | Reports (0) | Blogs (1239) | Audio/Video (3) | Fact Sheets (12) | Press Releases (66)
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zinc oxide topical (Desitin and Others) [Published MedicineNet.com - 8 mins ago]
EXCLUSIVE: Health officials search for experime... [Published New York Daily News - 23 mins ago]
Engineer I, Automation Engineering [Published PharmaDiversity - 27 mins ago]
Companies seek to benefit from Ebola [Published Boston Globe - 36 mins ago]
2014 AGM Chairman’s address [Published Noodls - 1 hour ago]
The Red Juice in Raw Red Meat Isn't Blood [Published Mercola - 1 hour ago]
Department Of Homeland Security Investigates Me... [Published Medical Design Online - 1 hour ago]
PROVECTUS BIOPHARMACEUTICALS : Taps INC Researc... [Published 4 Traders - 1 hour ago]
Vexim : to Initiate Clinical Study of SpineJack [Published 4 Traders - 1 hour ago]
Orexo : Files for Expanded Label of Zubsolv [Published 4 Traders - 1 hour ago]
C R Bard : FDA OKs Lutonix 035 Drug Coated Balloon [Published 4 Traders - 1 hour ago]
Pfizer : Reports Vaccine Candidate Data [Published 4 Traders - 1 hour ago]
Gilead Sciences : FDA Approvides Harvoni (Ledip... [Published 4 Traders - 1 hour ago]
Eisai : Gets FDA Approval of sNDA for Rufinamide [Published 4 Traders - 1 hour ago]
for healthier quickly weight loss [Published Scoop Asia - 3 hours ago]
that’s what they are doing about the exhibit [Published ListFree.Org - 3 hours ago]
1st IPA Pharmexcil Technical Seminar 2014 to be... [Published PharmaBiz - 3 hours ago]
The politics of dehumanization [Published The Nation Pakistan - 3 hours ago]
Sleeping pills do more bad than good [Published Individual.com - 3 hours ago]
Navidea names Rick Gonzalez chief executive off... [Published MolecularImaging.net - 4 hours ago]
Biogen Idec Suggests PML Risk Manageable For Te... [Published Health News Daily - 4 hours ago]
Expanded access – Myths, Truth and Behavior [Published Pharmaceutical Executive - 4 hours ago]
Long way from Chesapeake Bay [Published San Diego Reader - 5 hours ago]
Health officials warn of kids mistaking medicin... [Published FOX WFLD Chicago - 5 hours ago]
Tongue Sweeper (The Original & The Best) Availa... [Published NewsMaker - 5 hours ago]
“If this paper were about science,” says Geoffr... [Published American Council On Science & Health - 5 hours ago]
Minimize Regulatory Disruption to Patient Care ... [Published HIMSS - 5 hours ago]
FDA Holds Public Workshop on Medical Device and... [Published HIMSS - 5 hours ago]
United States Files Enforcement Action Against ... [Published United States Department of Justice - 5 hours ago]
A Senior Moment: What's new with Alzheimer's Di... [Published ChicoER.com - 6 hours ago]
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Blogs

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Lundbeck Provides Update on New Drug Applicatio... [Published Business Wire Health News - 9 hours ago]
DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck LLC announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application seeking approval of Carbella™ (carbamazepine) injection, an investigational ...
New FDA and BARDA Keynotes Provide Regulatory a... [Published Future of BioPharma - 13 hours ago]
We are excited to announce the addition of two keynote speakers to IBC's Vaccine Development Production Summit taking place December 8-9, 2014 in Boston, Massachusetts.- Tina Roecklin, Consumer Safety Officer of FDA offers regulatory perspective ...
ANS Update 10/24 “Nuclear Medicine” – National ... [Published Michele Kearney's Nuclear Wire - 13 hours ago]
← “Nuclear Safety” – National Nuclear Science Week, Day 4 (October 23) “Nuclear Medicine” – National Nuclear Science Week, Day 5 (October 24)Posted on October 24, 2014 by Will Davis | 1 Comment The fifth and last day of Nuclear Science Week ...
Long-Awaited FDA Report on LASIK Confirms Safet... [Published PR.com Press Releases - 14 hours ago]
Chicago, IL, October 24, 2014 --( PR.com )-- Results reported by the Food & Drug Administration (FDA) on a long-awaited comprehensive prospective, multi-center study on the safety and efficacy of LASIK were well-received by refractive surgeons in attendance ...
World: WHO convenes industry leaders and key pa... [Published ReliefWeb - Latest Updates - 14 hours ago]
Source: World Health OrganizationCountry: Guinea, World News release 26 24 October 2014 24 OCTOBER 2014 : GENEVA - The World Health Organization convened a meeting with high-ranking government representatives from Ebola-affected countries and development ...
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Audio/Video

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The FDA Approves An Expensive New Hepatitis Drug [Published Wall Street Journal What's News - Oct 10 2014]
Is Siberia a Safe Place for Smallpox? [Published Slate Magazine - Jul 15 2014]
The Persistent Danger of Poxes [Published Slate Magazine - Jul 11 2014]
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Press Releases

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Burzynski Research Institute, Inc. Announces FD... [Published Financial Services - 9 hours ago]
Rich Pharmaceuticals Announces Submission of In... [Published GlobeNewswire: Acquisitions News - Oct 23 2014]
MediciNova Announces FDA Granted Orphan Drug De... [Published GlobeNewswire: Acquisitions News - Oct 23 2014]
Relypsa Submits New Drug Application to U.S. FD... [Published GlobeNewswire: Acquisitions News - Oct 22 2014]
Tonix Pharmaceuticals Receives IND Clearance fo... [Published GlobeNewswire: Advertising News - Oct 21 2014]
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