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About 1084 results for "fda"

FDA: Screen blood supply for Zika

FDA says to check all blood donations for Zika

The Food and Drug Administration now recommends that all blood donations in the U.S. be screened for the Zika virus. The FDA previously advised screening only in areas with active Zika transmission, like parts of Florida and throughout Puerto Rico. Austin American Statesman, 1 hour ago
FDA: Screen blood supply for Zika CNN, 3 hours ago

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Cancer Therapy Advisor, 1 day ago
Cancer Therapy Advisor, 1 day ago
Food Marketing Institute, 1 day ago
MassDevice, 1 day ago
News, 1 hour ago
BioSpace, 2 days ago
Business Insider, 12 hours ago
Monthly Prescribing Reference, 2 days ago
Reuters, 12 hours ago
Vocativ, 3 hours ago
Food Logistics

A Reminder to our Friends in the Food Distribution Industry: Compliance Dates for FDA Food Safety Regulations Fast Approaching

Food & Drug Administration (FDA) has published several regulations in the past year that impact the United States food distribution industry, and the compliance date for two of these regulations is next month (September). The particular regulations ...
 Lexology6 hours ago New FDA food safety platform is launched to enable product tracking  China Post6 hours ago FDA Updates Benefit-Risk Determinations for New Medical Devices  National Law Review46 minutes ago New FDA Draft Guidance Shows Limited Compromise with Brand and Generic Drug Manufacturers  National Law Review1 hour ago

FDA Starts Showing Its Plans for Oversight of Pharmacy Compounding

—This spring and summer, FDA revealed in several guidance documents what the agency thinks pharmacy compounding should look like now that the relevant provisions in federal law are firmly in place and the agency has a budget for oversight. ...
 ASHP2 hours ago

Lupin secures tentative FDA nod for anti-depressant drug Paxil

Lupin can potentially market a generic version of Canada-based Apotex Technologies anti-depressant tablet Paxil CR tablets of the same dosage New Delhi: Lupin Ltd, the country's Mumbai-based third largest drug maker, said on Friday that it had ...
 Livemint.com11 hours ago US FDA grants approval to Jubilant's hypertension drug felodipine  Business Standard13 hours ago Strides Shasun receives US FDA approval for ranitidine tablets  PharmaBiz2 days ago Jubilant Life receives US FDA approval for hypertension drug telmisartan  Business Standard2 days ago
4 Traders

Mallinckrodt Receives FDA FastTrack Designation for Synacthen Depot IND Application

Mallinckrodt Receives FDA Fast-Track Designation for Synacthen® Depot IND Application Thursday, August 25, 2016 CHESTERFIELD, United Kingdom , Aug. 25, 2016 /PRNewswire/ --Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical ...
 Asian Hospital & Healthcare Management18 hours ago Mallinckrodt : muscular dystrophy drug receives FDA fast track designation  4 Traders8 hours ago BD Receives FDA Clearance for New Syringe Designed for the Administration of Humulin R U-500 Insulin  Global Hospital & Healthcare Management2 days ago Mallinckrodt Receives FDA Fast-Track Designation for Synacthen® Depot IND Application  Pharma Focus Asia15 hours ago

US FDA Consulting: Six Must-Read Scenarios

Make An Enquiry FDA consultants and regulatory strategists, we recognize that the space between nonprescription drugs, medical devices and prescription drugs FDA may consider ripe for Rx-to-OTC switches represent tremendous potential. Put ...
 Pharmaceutical Technology3 hours ago Six Must-Read Scenarios for FDA Consulting  Drug Development Technology3 hours ago

FDA Rejection Of Amgen Drug Does Nothing To Change Baird's Outlook On The Stock

Amgen, Inc. (NASDAQ: AMGN ) has received a CRL [complete response letter] in relation to Parsabiv, a calcimimetic under review by the FDA for secondary hyperthyroidism. This unexpected development is likely to have only a minimal material impact on ...
 Benzinga.com9 hours ago

Amgen gets US FDA complete response letter for Parsabiv NDA to treat secondary hyperparathyroidism

Amgen announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with ...
 PharmaBiz14 hours ago FDA rejects Amgen's Parsabiv NDA for secondary hyperparathyroidism; shares down 1% premarket  Seeking Alpha1 day ago BRIEF-Amgen says FDA issues complete response letter for NDA for Parsabiv  Reuters UK2 days ago FDA rejects Amgen's filing for Parsabiv in secondary hyperparathyroidism  FirstWord Pharma1 day ago

Smart Syringe Pumps Can Err at Low Flow Rates, FDA Warns

Clinicians using programmable, or smart, syringe pumps should take precautions against mishaps that can occur at low infusion rates of high-risk, life-sustaining therapies, such as those at less than 5 mL per hour, and especially those at less than ...
 Diabetes Care23 hours ago FDA Warns of Problems With Programmable Syringe Pumps  P&T Community5 hours ago FDA Alert: Problem with Fluid Flow of Programmable Syringe Pumps  PharmaceuticalProcessing8 hours ago

US FDA shoots warning letter to Frontida BioPharm

MUMBAI - Issues related to violations of data and manufacturing practices is back in the spotlight for the Indian pharmaceutical industry. An August 15 warning letter from the US FDA to Frontida BioPharm, a company that acquired two manufacturing ...
 Economic Times17 hours ago FDA Hands Out 15 Warning Letters to Devicemakers for GMP Violations  FDA News3 days ago
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