 FDA Requesting Firms Update User Fee Product Lists by Mid-JuneWith the FDA anticipating publishing fiscal year (FY) 2009 drug user fees this August, the agency is asking manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16. Read More
No Clinical Trials Required for Sandoz’ Generic LovenoxThe FDA will not require human clinical trials to support the ANDA for Sandoz and Momenta’s generic version of the anticoagulant Lovenox, which previously received a not-approvable letter. Read More
Pharmaxis Moving Forward With Design of Phase III Bronchitol TrialFollowing advice from the FDA on the design of its pivotal Phase III trial for its mucus-clearing agent Bronchitol, Pharmaxis will begin the trial during the third quarter of this year. Read More
FDA Official Sees Push for Clinical Trial RulesThe FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials. Read More
Boston Scientific Granted European Approval for Advanced PacemakersBoston Scientific was given European CE Marking for its new ALTRUA family of pacemakers. Read More
Vascular Insights Receives FDA Clearance for Infusion CatheterVascular Insights has achieved 510(k) clearance from the FDA to market its ClariVein infusion catheter. Read More
Sponsored by:
FDA Official Sees Push for Clinical Trial RulesThe FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials. Read More
Boston Scientific Granted European Approval for Advanced PacemakersBoston Scientific was given European CE Marking for its new ALTRUA family of pacemakers. Read More
Vascular Insights Receives FDA Clearance for Infusion CatheterVascular Insights has achieved 510(k) clearance from the FDA to market its ClariVein infusion catheter. Read More
GE’s Surgery Division Gets Green Light to Resume ProductionThe FDA cleared GE Healthcare to resume full-scale manufacturing at its OEC Medical System division early this month, marking an end to the company’s yearlong effort to bring its X-ray surgical imaging systems operations into compliance. Read More
Companies to Develop Computer-Assisted Diagnostic Test for Cervical CancerHealth Discovery Corp. and DCL Medical Laboratories signed a letter of intent to jointly develop a computer-assisted diagnostic test for cervical cancer. Read More
Dilon Receives CE Marking for Medical Imaging System Gamma CameraDilon Technologies has received CE Marking for its Dilon 6800 gamma camera. Read More
No Clinical Trials Required for Sandoz’ Generic LovenoxThe FDA will not require human clinical trials to support the ANDA for Sandoz and Momenta’s generic version of the anticoagulant Lovenox, which previously received a not-approvable letter. Read More
Pharmaxis Moving Forward With Design of Phase III Bronchitol TrialFollowing advice from the FDA on the design of its pivotal Phase III trial for its mucus-clearing agent Bronchitol, Pharmaxis will begin the trial during the third quarter of this year. Read More
Advisory Committees Vote No to Expand Fentora UseTwo FDA advisory committees said concerns over Fentora’s potential for addiction were too strong to let Cephalon expand the use of its cancer pain drug to treat opioid-tolerant, noncancer, chronic pain patients with breakthrough pain. Read More
USPTO Confirms Validity of Lipitor PatentThe U.S. Patent & Trademark Office (USPTO) has notified Pfizer that it will confirm the viability of the company’s ’893 basic patent for cholesterol drug Lipitor. Read More
Teva Sees Significant Copaxone Sales in First QuarterSales of Teva’s multiple sclerosis drug Copaxone grew by 35 percent to $542 million during the first quarter of the year compared with the first quarter of 2007. Read More
Fifth Annual Medical Device Quality Congress
|
|