Regulatory and Drug Approvals News
Regulatory Affairs and Drug Approvals News
FDA Unveils Safe Use Initiative That Targets Preventable Harm From Medication Use
The U.S. Food and Drug Administration announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. "Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems.
FDA Awards Absorption Systems Phase II SBIR Grant For CellPort Technologies™
Absorption Systems LP announced that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant from the U.S. Food and Drug Administration (FDA) to continue development of the company's CellPort Technologies™ testing platform. This unique assay platform enables more specific prediction of potential drug-drug interactions mediated by human drug transport proteins.
First Device Designed To Preserve Blood Flow To Iliac Arteries During Aneurysm Repair Receives Approval From Health Canada
Canadian physicians can now treat patients suffering from life-threatening aneurysms in one of the body's largest arteries with an endovascular graft delivered during a minimally invasive procedure without blocking a critical artery.
FDA Awards Absorption Systems Phase II SBIR Grant For CellPort Technologies™
Absorption Systems LP announced that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant from the U.S. Food and Drug Administration (FDA) to continue development of the company's CellPort Technologies™ testing platform. This unique assay platform enables more specific prediction of potential drug-drug interactions mediated by human drug transport proteins.
FDA Approves New Salix Product Exclusively In Catalent's Zydis(R) Fast Dissolve Technology
Catalent Pharma Solutions, one of the leading advanced drug delivery technology providers to the pharmaceutical industry, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Metozolv™ ODT (orally disintegrating tablets) metoclopramide HCL utilizing Catalent's Zydis® fast dissolve technology.
FDA Publishes Guidance On Diagnostic Tests For 2009 H1N1 Influenza Virus
The U.S. Food and Drug Administration published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA).
FDA, JIFSAN Travel To Bangladesh To Teach Seafood Safety
The U.S. Food and Drug Administration and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) have sent a team of seafood specialists to Bangladesh this week to help train local officials on aquaculture safety and quality control techniques.
New Tests For Identifying Potentially Deadly Adulterants In Pharmaceutical Ingredients
To further protect patients from adulterated medicines, the U.S. Pharmacopeial Convention (USP) has announced revised standards for four ingredients widely used in prescription and over-the-counter drugs.
Covidien Receives FDA Approval For Oral Transmucosal Fentanyl Citrate Product
Covidien (NYSE: COV), a leading global provider of healthcare products, announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII). Covidien's product is a generic alternative to the branded ACTIQ®.
Mentor Capital, Inc. Rated A $5/sh Speculative Buy On Immune System Breast Cancer Treatment In FDA Phase I/II Trials
Mentor Capital, Inc. (Pink Sheets: MNTR) is well poised to be a significant participant in the expanding medical sector of Cancer Immunotherapy with a $5 price objective according to Senior Securities Analyst Howard N. Stillman. That implied 165% gain over the current $1.
