je.st
news
Tag: fda
Judge criticizes FDA move on Plan B, agency warns of precedent
2013-05-08 15:38:00| Biotech - Topix.net
A federal judge criticized the Food and Drug Administration over its refusal to make emergency contraception available to girls of all ages without a prescription, saying the agency's move to restrict distribution to consumers aged 15 and older was not realistic.
Merck Announces FDA Acceptance of Biologics License Application for Investigational Ragweed Pollen Sublingual Allergy Immunotherapy Tablet
2013-05-08 14:30:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet has been accepted for review by the U.S. Food and Drug Administration (FDA). On March 27, Merck announced that the FDA had also accepted the BLA for its investigational Timothy grass pollen (Phleum pratense) sublingual allergy immunotherapy tablet. Language: English Contact HTML: MerckMedia:Pam Eisele, 908-423-5042Robert Consalvo, 908-423-6595orInvestor:Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Tags: application
license
acceptance
announces
Maxim Surgical Achieves FDA Clearance for New Spinal Implants Made of Solvay's ...
2013-05-07 06:00:00| Industrial Newsroom - All News for Today
Thermoplastic Biomaterial Delivers High Performance in New MaxFuse-C™ Cervical Interbody Fusion System<br /> <br /> ALPHARETTA, Ga. – Maxim Surgical, a new designer and manufacturer of spinal implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new MaxFuse-C™ cervical interbody fusion system made of Zeniva® polyetheretherketone (PEEK) rods from Solvay Specialty Polymers. Zeniva® PEEK – part of Solvay's line of Solviva® ...This story is related to the following:Materials and Material ProcessingSearch for suppliers of: Biomaterials |
Tags: of
made
clearance
surgical
ICMAD Comments on FDA Findings
2013-05-06 07:00:00| Happi Breaking News
In correlation to recent lipstick report.
Tags: comments
findings
fda
fda comments
FDA Clears Masimo Rainbow® Acoustic Monitoring(TM) Sensor for Use on Pediatric Patients
2013-05-06 06:00:00| Industrial Newsroom - All News for Today
Acoustic Respiration Rate (RRa™) Now Offers Accuracy, Ease of Use and Enhanced Tolerance for Pediatric Patients<br /> <br /> IRVINE, Calif. - Masimo (NASDAQ: MASI) announced today that its rainbow® Acoustic Monitoring™ sensor, RAS-125c Acoustic Respiration Cloth Sensor has received U.S. FDA 510(k) clearance for continuous, noninvasive monitoring of acoustic respiration rate (RRa™) in pediatric patients. Previously FDA-cleared for adult use, clinicians can now use the RAS-125c ...This story is related to the following:Medical Sensors | Respiratory Monitors
Tags: patients
sensor
acoustic
pediatric
Sites : [191] [192] [193] [194] [195] [196] [197] [198] [199] [200] [201] [202] [203] [204] [205] [206] [207] [208] [209] [210] next »