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About 1303 results for "fda"

FDA Refines Its Understanding And Validation Within The Contexts Of Process Validation Terminology
PRWeb

FDA Refines Its Understanding And Validation Within The Contex...

The FDA has refined its understanding and validation for product, software and processes used for medical production. Protomatic demonstrates its method for adopting the four protocol: design qualification (DQ), installation qualification (IQ), ... PRWeb, 6 hours ago
FDA expanded use of eye drug CNBC, 11 hours ago
FDA OKs label expansion for Eylea Seeking Alpha, 12 hours ago
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8,030 images for fda

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US News & World Report

FDA Should Not Regulate E-Cigarettes as Tobacco Products

The Food and Drug Administration's Center for Tobacco Products has two goals that seem to go hand-in-hand: Reduce tobacco use, and reduce the number of smoking-related diseases and deaths. If there was a product that was achieving both goals, why ...
 US News & World Report1 hour ago Maha: FDA extends ban on tobacco & tobacco-related products  Business Standard1 week ago FDA extends ban on tobacco and tobacco-related products  DNA1 week ago How the FDA Chief Deals With Disappointed Patients and E-Cigs  Business Week2 months ago
Pharma Letter

Ranbaxy down on same quarter last year following FDA fine

Indian generic pharma company Ranbaxy (NSE: RANBAXY), has reported consolidated sales of 23.7 billion rupees ($394 million), with earnings before interest, tax, depreciation and amortization standing at Rs. 2.4 billion. The quarter to the end of ...
 Pharma Letter50 minutes ago U.S FDA Ban Ranbaxy: Stocks Dip!  Silicon India3 weeks ago Ranbaxy results on Friday, but sentiment to remain tepid on other concerns: Analysts  Business Line2 months ago DCGI suspends Ranbaxy’s supply  Asian Age1 month ago

Ampio Pharmaceuticals announces the FDA has issued a written response and accepted the Ampio plan for beginning production of Ampion in the new facility.

/PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a positive written response from the FDA in regards to the company's plans to begin production of Ampion TM in our new drug manufacturing facility. Dr. Vaughan Clift , ...
 Tamar Securities1 hour ago
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RTTNews.com

BRIEF: Medical startup seeks FDA approval for lung-disease product [The Sacramento Bee :: ]

July 29--A Sacramento medical-device startup and its partners are about to seek U.S. Food and Drug Administration approval for its first product, a home-purification system aimed at fighting lung infections in cystic fibrosis patients. The Asthma & ...
 BusinessWeek16 hours ago FDA Approves Over-The-Counter Flonase Allergy Relief  RTTNews.com17 hours ago Gilead's Zydelig Approved By FDA For 3 Blood Cancers  Bioresearch Online19 hours ago House passes bill to speed FDA's sunscreen approvals  FOXNews.com1 day ago
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Pharma Letter

Impax smacked after FDA inspection

15:53 ET | About: Impax Laboratories, Inc. (IPXL) Shares of Impax Laboratories (IPXL -14.6%) plunge on a 7x surge in volume after an FDA inspection of its Taiwan manufacturing facility. The site makes 12 products for U.S. distribution and will ...
 Seeking Alpha18 hours ago Impax skids after company says FDA cites possible problems in inspection of Taiwan facility  FOXBusiness.com18 hours ago FDA Performs Inspection of Impax's Taiwan Facility  BusinessWeek1 day ago Impax Labs shares slump after FDA inspection  Wall Street Business Network17 hours ago
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FDA Wants More Info on AcelRx Pain Drug Device Zalviso

Reuters Health Information By Reuters Staff July29,2014 (Reuters) - The U.S. Food and Drug Administration has asked for more information on the pain drug device, Zalviso, from AcelRx Pharmaceuticals, the company said. The needle-free, ...
 Diabetes Care16 hours ago AcelRx falls on FDA rejection  Yahoo! Finance1 day ago AcelRx stock plunges 40% after FDA rejects pain drug device  TheStar.com.my1 day ago AcelRx Pharma Plunges After FDA Rejects Device  Investor's Business Daily1 day ago
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Reuters

Drug Naming Process Gets New Scrutiny From FDA

By Posted at 10:30 a.m. July 29 (Oli Scarff/) The Food and Drug Administration on Monday issued a notice seeking comments on the process of naming prescription drugs , particularly drug manufacturers desire to reserve a specific name for a ...
 Roll Call Online22 hours ago 7/30/14 - CorMatrix Gets FDA Approval to Market ECM for Vascular Repair [Professional Services Close - Up]  Pharmacy Choice2 hours ago 7/29/14 - Vascular Pathways Gets FDA Clearance for AccuCath [Professional Services Close - Up]  Pharmacy Choice1 day ago Ranbaxy gets nod for new generic BP drug  Business Line1 month ago
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SORIN GROUP: APPROVAZIONE FDA PER SOLO SMART LA PIÙ RECENTE EVOLUZIONE NELLA TECNOLOGIA DELLE PROTESI VALVOLARI BIOLOGICHE

MILANO--( BUSINESS WIRE )--Sorin Group (MIL:SRN) (Codice Reuters: SORN.MI), azienda medica globale e leader nel trattamento della malattie cardiovascolari, ha annunciato oggi di avere ottenuto lapprovazione della U.S. FDA (Food and ...
 Business Wire1 day ago FDA approves Sorin heart valve  Seeking Alpha1 day ago FDA approves Sorin's Solo Smart aortic pericardial heart valve  Medical Devices Business Review4 hours ago Sorin Group Announces FDA Approval of Solo Smart the Next Evolution in Tissue Valve Technology  Quoteline1 day ago
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U.S. FDA raises concerns about Impax's Taiwanese plant

July 29 (Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued "certain observations" after an inspection of the company's manufacturing plant in Taiwan. The regulator issued a ten observations in a Form 483, which ...
 CNBC1 day ago Impax now faces FDA issues at Taiwan plant that could affect Rytary  FiercePharmaManufacturing21 hours ago IMPAX LABORATORIES : FDA Issues Inspection Observations of Impax's Taiwan Facility  4 Traders1 day ago Impax Parkinson's drug future shaky as FDA flags factory issues  Reuters1 day ago
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