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    FDA to Unveil New Regulatory Framework for Stem Cell Therapies

    The US Food and Drug Administration's (FDA) Commissioner Scott Gottlieb said Monday the agency will advance a new framework to better regulate stem cell therapies this fall. "This comprehensive policy will establish clearer lines around when these regenerative medicine products have sufficient complexity to fall under the agency's current authority, and then define an efficient process for how these products should be evaluated for safety and effectiveness," Gottli...
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    FDA Weighs Limited Risk Info in DTC Ads

    The US Food and Drug Administration (FDA) on Friday announced it is considering a new approach to presenting risk information in direct-to-consumer (DTC) television and radio ads that would allow drugmakers to limit the amount of risks presented. Currently, DTC drug ads are required to present a product's major risks alongside its benefits to ensure a "fair balance" of information. But FDA and industry have long debated over the best way to present that information. Acc...
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    PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion

    The pharmaceutical industry lobbying group is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health. "FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further pro...
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    FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

    A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks. According to the study, limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also impro...
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    Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising

    Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system." With the intention of addressing the criticisms of the current system from a public consultation on  the regulatory framework for advertising therapeutics  in November 2016, the decision means all complaints...
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    Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Ratchets up Pressure on Abbott, Medtronic to Keep Supplying Stents The National Pharmaceutical Pricing Authority (NPPA) of India has stepped up its attempts to stop Abbott Healthcare and Medtronic from curbing supply of their high-end cardiac stents. NPPA’s latest move is to encourage hospitals, doctors and patients to tell it if there is a shortage of certain br...
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    Asia Regulatory Roundup: Australia Considers Some DTC Drug Ads (4 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Changes to Oversight of Low-Risk OTC Products The Therapeutic Goods Administration (TGA) of Australia has put forward proposed changes to the regulation of low-risk products for consultation. TGA is seeking feedback on whether it should free some over-the-counter (OTC) medicines from the need to go through premarket assessments. Currently, TGA c...
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    FDA Warns Two Pharma Companies Over Misleading Ads

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent two warning letters earlier this week for misleading advertisements. One of the warnings was sent to Salt Lake City-based Spiraso due to “false or misleading claims and/or representations about the risks associated with Tuxarin ER” on the company’s website. Tuxarin is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults ...
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    Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Prepares Changes to Advertising Complaints Process The Therapeutic Goods Administration (TGA) of Australia is seeking industry feedback on the reform of the advertising complaints management process. TGA is considering either setting up a centralized process for handling complaints or outsourcing some or all of the work to an independent authority and wants to get...
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    FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine). The letter, the fifth of which was issued this year by OPDP (the last one was issued in September), focuses on the video’s use of the general terms “e...
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    Regulating Precision Medicine: Capacity vs. Overreach

    As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine. In an article published online this week in the Journal of Law and the Biosciences , titled “Precision medicine: drowning in a regulatory soup?” a group of mostly Australian researchers note that...
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    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...