Do brands matter in pharma? Not as much as outcomes
January 30, 2018
By Neozene

Pharma brands don’t matter nearly as much to consumers as results when it comes to new drugs, according to a new report. Accenture Life Sciences found that 69% of patients said product benefits were more important than brand. Only 25% ranked brand loyalty or popularity as a top factor in their healthcare and product and treatment decisions. So instead of spending millions on brand advertising—or maybe along with it—pharma companies should be thinking about promoting evidence-based solutions that will appeal to these patients, Jim Cleffi, managing director at Accenture Life

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FDA slaps Mexico’s Prosana with warning letter – In need of compliant quality solutions?
January 11, 2018
By Neozene

Five months after blocking the products of Prosana Distribuciones from the U.S., the FDA has issued a warning letter for the Mexican company. The letter, which was issued December 18, follows an import alert for the company issued in August after the FDA found out that employees had not been testing APIs and admitted they had falsified some batch records for the OTC products it was shipping to the U.S. The warning was the result of an inspection in March 2017 at the Mexico City facility and followed some back

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US Regulators Refine Least Burdensome Provisions for Medical Device Oversight
January 3, 2018
By Neozene

Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. FDA’s latest draft guidance on Least Burdensome Provisions will replace guidance on the topic issued in 2002; recently passed US laws including the FDA Safety and Innovation Act (FDASIA) and the 21st Century Cures Act expanded upon Least Burdensome Provision concepts and principles, necessitating revised guidance. Broader scope of applicability The updated FDA Least Burdensome Provisions apply across all major FDA medical device regulatory activities and processes, including 510(k)

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