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FDA Continues to Reduce Generic Drug Backlog The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700.FDA Warns of Risks From Fluid-Filled Stomach Balloons to Treat Obesity Published 09 February 2017.

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Generic Version of Viagra Coming in 2017. because the introduction of less expensive generic competitors causes sales.The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled stomach balloons used to treat obesity.FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information.

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TTIP on Thin Ice Likely to Delay US-EU Mutual GMP Recognition Deal.There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.Access My Courses Regulatory Affairs Certificate Program Online Learning Solutions Regulatory Affairs Certification (RAC) The Regulatory Convergence Executive Development Event Calendar.Login to access your membership accounts, education training and products and services.Generic giant Mylan also agreed with Pfizer not to launch its generic version of Viagra until 2017.Pfizer Inc. has reached a settlement with Teva Pharmaceuticals that allows the generic drugmaker to launch a copycat version of its popular erectile dysfun.Viagra Sales Statistics 2017 a profitable business demands much more than good business sense.

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Pfizer posted disappointing profit for the fourth quarter to cap a difficult 2016, but it predicted slightly better results for this year.European Regulatory Roundup: EMA Recommends Approval of First Monoclonal Antibody Veterinary Medicine (23 February 2017) Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

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Teva spokeswoman Denise Bradley told Focus that because of a 2013 pay-for-delay settlement with Pfizer, Teva has agreed to not launch the generic until December 2017.NYSE: PFE GO. downbeat sales outlook. 6:57 a.m. Jan. 31, 2017.

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