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About 1292 results for "fda"

TransTech Pharma Hits Pact with FDA

TransTech Pharma reported that it has reached an agreement with the U.S. Food and Drug Administration Division of Neurology Products, under the Special Protocol Assessment process, on the design of a single Phase 3 trial of TTP488 for the treatment ..., 2 hours ago

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BusinessWeek, 13 hours ago
MassDevice, 1 day ago
McLean Patch, 9 minutes ago, 1 hour ago
Money Today, 1 day ago
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NDTV Profit, 1 day ago, 1 day ago
ABC News 4 Charleston, 15 hours ago, 2 days ago
MedPage Today

FDA issues revised draft guidance on Reporting Drug Sample Information Under the ACA

On July 11, FDA issued new draft guidance concerning drug sample reporting mandated under the Affordable Care Act (ACA). The guidance, Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act, replaces agency's earlier April ...
 Lexology4 minutes ago FDA holds teleconference re: social media guidance  Lexology18 hours ago FDA Issues Informed Consent Guidance  MedPage Today9 hours ago FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms  JD Supra9 hours ago

Dompe announces the Food and Drug Administration (FDA) has granted orphan drug designation to its rhNGF-based treatment for neurotrophic keratitis

- The candidate drug, developed in Italy in the L'Aquila laboratories of the Biopharmaceutical Group, finds its origins in the research of Nobel Prize winner Rita Levi Montalcini. - Neurotrophic keratitis is a rare disease that affects less than ...
 OSIX News1 hour ago FDA releases more information on smallpox incident  BioPrepWatch14 hours ago FDA's Mini-Sentinel Pilot Program Mines Billing Codes to Predict Adverse Drug Events  Becker¬ís Hospital Review1 day ago Absconding Fatehabad drug controller suspended  Times of India1 week ago

A collection of approx..1100 FDA approved drugs in pre-dissolved 100ul of DMSO solution for high throughput screening (HTS) and high content... [TendersInfo (India)]

A collection of approx..1100 FDA approved drugs in pre-dissolved 100ul of DMSO solution for high throughput screening (HTS) and high content screening (HCS). It should be stored in screw cap tubes in Contract awarded for A collection of ...
 Pharmacy Choice5 minutes ago FDA approves many drugs that up heart and stroke risk  TopNews1 month ago

FDA releases draft guidance on benefit and risk analysis for 510(k)s

The FDA recently released a draft guidance titled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. The draft guidance is intended to help FDA ...
 Lexology23 minutes ago What's Safety and Effectiveness Got to Do with Substantial Equivalence? FDA Clears it Up.  JD Supra3 hours ago
Med India

7/23/14 - United States : VENITI receives FDA approval for VICI VENOUS STENT SYSTEM [TendersInfo (India)]

U.S. Food and Drug Administration has sanctioned Veniti for one of its devices that looks to treat venous disease. Veniti was approved for its Vici Venous Stent System, which is a stent that is particularly designed for veins. Veniti has utilized ...
 Pharmacy Choice31 minutes ago Veniti gets FDA approval for medical device  Big News Network1 day ago QT Vascular Gets FDA Nod for Chocolate PTCA Balloon Catheter  Med India1 month ago Perfint Healthcare's MAXIO Gets FDA Approval  Med India1 month ago

Berry Genomics to secure Chinese FDA nod for Illumina's NGS system to provide cost-effective, easy-to-use assay for NIPT

Biotechnology company Berry Genomics Co. Ltd. has chosen Illumina Inc's next-generation sequencing (NGS) technology as the platform on which Berry will secure Chinese Food and Drug Administration (CFDA) regulatory approval for clinical applications, ...
 PharmaBiz59 minutes ago
Industrial Info Financials

Boston's latest generation bare-metal stent, Rebel Platinum Chromium Coronary Stent System gets US FDA approval

Boston Scientific Corporation, global medical technology leader, has received the US Food and Drug Administration (FDA) approval for the Rebel Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the ...
 PharmaBiz2 hours ago Sucampo says FDA approves addition of Nitto Medic as Rescula production site  Yahoo! Finance12 hours ago Medicines360 and Actavis files Levosert IUD's NDA for US FDA's substantive review  Individual.com18 hours ago US FDA accepts Medicines360's NDA for Levosert IUC  PharmaBiz19 hours ago

Summit Medical Secures FDA Clearance for Sterilization Methods

Summit Medical gain FDA clearance for sterilization methods on their instrument protection trays. According to a release from the company, these validations serve as a safeguard, to ensure the product will not inhibit sterility of valuable surgical ...
 Individual.com3 hours ago Expanded FDA Clearance of Synergy Biomedical's Biosphere Putty  Medical Design Technology1 day ago FDA 510(k) Clearance for Varian Medical Systems Calypso Soft Tissue Beacon Transponder  Medical Design Technology1 day ago FDA clears Beacon transponder  Seeking Alpha1 day ago

US FDA accepts Avanir Pharma's IND application for phase II study of AVP-786 for adjunctive treatment of MDD

The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals, Inc.'s Investigational New Drug (IND) application for a phase II study assessing the safety and efficacy of AVP-786, Avanir's next generation compound. The company plans ...
 PharmaBiz20 hours ago FDA fast-tracks Roche's Avastin for tough-to-treat ovarian cancer  FierceMedicalDevices1 hour ago FDA grants Roche's Avastin priority review for ovarian cancer  Reuters1 day ago FDA OK's Phase 2 study of Avanir MDD candidate  Seeking Alpha1 day ago
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