 Novartis Sees Positive Phase III Data for COPD CandidateNovartis’ chronic obstructive pulmonary disease (COPD) candidate bested placebo in improving lung function, symptom relief and quality of life in a Phase III trial, setting it up for a 2014 U.S. filing. Read More
EU-Style Device Approval Poses Patient Safety Risks, FDA SaysManufacturers hoping the FDA might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report. Read More
Canada Increases Device User Fees, Agency Under the Gun for Missing GoalsUser fees for medical device license and renewal rose 2 percent in Canada, effective April 1. Read More
EMA Biosimilars Q&A Aims to Clarify Presubmission Issues, Review TimelinesThe European Medicines Agency (EMA) has published a question-and-answer guideline on marketing applications for biosimilars, providing advice on a number of presubmission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing. Read More
FDA Panel Recommends Arena’s Obesity Drug LorcaserinAn agency advisory panel voted 18–4 with one abstention in favor of approval for Arena’s weight-loss drug lorcaserin. Read More
EU-Style Device Approval Poses Patient Safety Risks, FDA SaysManufacturers hoping the FDA might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report. Read More
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EU-Style Device Approval Poses Patient Safety Risks, FDA SaysManufacturers hoping the FDA might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report. Read More
Canada Increases Device User Fees, Agency Under the Gun for Missing GoalsUser fees for medical device license and renewal rose 2 percent in Canada, effective April 1. Read More
Medicare DME Savings Exact Toll on Suppliers, Access to CareTouted for saving Medicare millions, a federal competitive bidding program for durable medical equipment (DME) may be limiting beneficiary access to some devices as supplier numbers plunge. Read More
Panel Urges EU to Adopt More SME-Friendly Device Regulations, Payment PoliciesA panel of European medtech experts is calling for simplified, more efficient reimbursement policies and purchasing procedures to reduce barriers to speed access to novel devices developed by small and medium-sized enterprises (SMEs). Read More
AdvaMed to Put Dedicated Staff in Three Emerging MarketsAdvaMed will add full-time staff on the ground in China, Brazil and India over the next three years under a new strategic plan unveiled April 19. Read More
No Sunshine in 2012: Physician Reporting Rules Pushed Back AgainThe Centers for Medicare & Medicaid Services (CMS) is sparing devicemakers and group purchasing organizations from reporting payments made to doctors and hospitals in 2012, as the agency continues to lag behind deadlines for issuing final Sunshine Act regulations. Read More
EMA Biosimilars Q&A Aims to Clarify Presubmission Issues, Review TimelinesThe European Medicines Agency (EMA) has published a question-and-answer guideline on marketing applications for biosimilars, providing advice on a number of presubmission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing. Read More
FDA Panel Recommends Arena’s Obesity Drug LorcaserinAn agency advisory panel voted 18–4 with one abstention in favor of approval for Arena’s weight-loss drug lorcaserin. Read More
Senate Updates PDUFA V Language, Plans Vote for Next WeekThe Senate plans to debate and vote on an omnibus FDA user fee bill next week, as lawmakers Tuesday substituted a new bill for the prior reauthorization bill. Read More
EMA Calls for Documentation of Biologic Manufacturing ProcessesDrugmakers seeking approval for biologics trials in the EU must describe and justify their manufacturing processes and process controls, ideally with a flow chart of all steps, the European Medicines Agency (EMA) says. Read More
Abbott Agrees to $1.6 Billion Fine, Five-Year CIA for Depakote PromotionAbbott Laboratories has agreed to pay $1.6 billion in civil and criminal penalties and submit to a five-year corporate integrity agreement (CIA) to resolve a Justice Department probe into its marketing of antipsychotic Depakote. Read More
Conducting Bulletproof CAPA Investigations — ADVANCED
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