 Amgen’s Denosumab Bests Novartis’ Zometa in Metastatic Breast CancerAmgen’s investigational oncology drug denosumab proved superior to Novartis’ Zometa in a Phase III clinical trial treating breast cancer patients with bone metastases. Read More
Actavis Introduces Generic Viagra in BulgariaActavis has become the first company to start selling a generic version of Pfizer’s erectile dysfunction drug Viagra in Bulgaria. Read More
Possible Excess Active Ingredient Leads to Bladder Drug RecallNiche Generics has begun a Class I recall of all remaining stock of four batches of oxybutynin HCl 5-mg tablets that might contain too much of the drug’s active ingredient. Read More
EMEA Lays Out Timeline for Advanced TherapiesThe European Medicines Agency (EMEA) has issued recommendations on application procedures for makers of advanced therapies — including combination products and tissue-engineered devices — seeking approvals from the agency’s Committee for Advanced Therapies (CAT). Read More
Warning Letter: Plastic Bag, Envelope May Not Suffice as Device PackagingFfrench Emergency Pocket Airway did not ensure that distributing devices in plastic bags packed in padded envelopes is enough to protect them from alteration or damage, according to a recent FDA warning letter. Read More
FDA Tightens Overdose Warnings for Propoxyphene Pain DrugsThe FDA is requiring manufacturers of Darvon, Darvocet and other propoxyphene-containing drugs to strengthen the labeling information on the drugs’ overdose risk, including the boxed warning. Read More
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EMEA Lays Out Timeline for Advanced TherapiesThe European Medicines Agency (EMEA) has issued recommendations on application procedures for makers of advanced therapies — including combination products and tissue-engineered devices — seeking approvals from the agency’s Committee for Advanced Therapies (CAT). Read More
Warning Letter: Plastic Bag, Envelope May Not Suffice as Device PackagingFfrench Emergency Pocket Airway did not ensure that distributing devices in plastic bags packed in padded envelopes is enough to protect them from alteration or damage, according to a recent FDA warning letter. Read More
Documentation Problems Lead to ObservationsDevicemaker Medical Accessories was cited with multiple Form 483 observations related to incomplete documentation. Read More
FDA Approves Medical Isotope From Australian ReactorMolybdenum 99 (Mo-99) produced by the Open Pool Australian Light-water (OPAL) reactor has been approved for use in the U.S., Mary Taylor, vice president of global regulatory affairs for Lantheus Medical Imaging, said. Read More
US FDA Pushes for Increased GHTF Participation at Home and AbroadIncreasing the participation of Asian countries in the Global Harmonization Task Force (GHTF) is the most important issue facing it. Read More
Law Firm: AMO Failed to Disclose Infections Tied to Lens SolutionAbbott Laboratories subsidiary AMO did not disclose multiple reports of serious eye infections connected to use of its contact lens solution for more than a year, according to an FDA Form 483 released by law firm Schmidt & Clark. Read More
Actavis Introduces Generic Viagra in BulgariaActavis has become the first company to start selling a generic version of Pfizer’s erectile dysfunction drug Viagra in Bulgaria. Read More
Possible Excess Active Ingredient Leads to Bladder Drug RecallNiche Generics has begun a Class I recall of all remaining stock of four batches of oxybutynin HCl 5-mg tablets that might contain too much of the drug’s active ingredient. Read More
FDA Tightens Overdose Warnings for Propoxyphene Pain DrugsThe FDA is requiring manufacturers of Darvon, Darvocet and other propoxyphene-containing drugs to strengthen the labeling information on the drugs’ overdose risk, including the boxed warning. Read More
Expert: PIs Bear Responsibility for Adverse Event ReportingPrincipal investigators (PIs) have the primary responsibility for deciding what to report as an adverse event or serious adverse event and for filing the reports. Read More
Matrix’ Lamivudine Tablets Tentatively ApprovedThe FDA has given tentative approval to a 300-mg dose of lamivudine tablets, Matrix Laboratories’ generic version of GlaxoSmithKline’s HIV drug Epivir. Read More
Medical Device Compliance Institute 2009:
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