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Scientific Exchange: Grey Areas and Best Practices

Oct 11, 2019 · Scientific Exchange vs. Promotion (cont’d) •#4 Venue Scientific forums such as medical congresses are more likely to be viewed as conducive to scientific exchange, as opposed to locations or events where promotional activities are conducted •#5 Commercial involvement Absence or limitation of commercial involvement can help mitigate 

OffLabel Promotion Or Scientific Exchange A Multimillion

Jul 02, 2015 · Other federal laws 4 and agency guidances 5 address off-label promotion, but FDA never explicitly defines what constitutes scientific exchange, though it has been attempting to do so. 6 Still, companies can infer FDA’s definition of scientific exchange through the “safe harbors” present in agency guidances: FDA permits manufacturers to 

Scientific Exchange of Information Differs From Promotion

Jan 28, 2009 · Scientific Exchange of Information Differs From Promotion. January 28, 2009. Although the FDA does not define scientific exchange versus promotion in its regulations, whether something is product promotion determines the level of … 

Scientific Exchange of Information Versus Promotion | FDAnews

May 07, 2008 · Scientific Exchange of Information Versus Promotion. May 7, 2008. Although the FDA does not define scientific exchange versus promotion in its regulations, distinguishing between the two is relevant because whether something is product promotion determines the level of government regulation and oversight. 

Scientific Exchange: What Every Compliance Officer Should

Oct 21, 2015 · vs. Scientific Exchange › FDA needs to align its promotion policies with 1st Amendment expectations Pharma and device companies will use Amarin to bolster defense against off-label allegations However, an effective Compliance program is still needed. Amarin: Potential Implications 

Drug Promotion and Scientific Exchange — The Role of …

Conventional methods of drug promotion — such as print advertising, direct marketing by salespeople, and the distribution of written materials at meetings — have increasingly been supplemented 

Dissemination of Clinical Trial Information: It’s a Fine

Scientific Exchange vs. Promotion My Thoughts • Education vs. spin • Context and perception solicited vs. unsolicited request marketing vs. medical affairs greatest hits vs. entire reprint • Relevance is the level of FDA regulation and oversight 

Scientific Exchange/Safe Harbor | BIO

Scientific Exchange is an FDA regulation that is codified in the Code of Federal Regulations, or CFR, as Section 312.7(a) Scientific exchange occurs when companies exchange medical and scientific information or data in a non-promotional context, or in response to unsolicited questions from healthcare professionals, healthcare organizations, patient advocacy groups, and third … 

FDA Regulation of Pharmaceutical Marketing

– Scientific Exchange Press Releases • Present the results of a study but do not draw conclusions or include any promotional efficacy/safety claims – Clinical Study Reprints under FDAMA • Restricted to new uses of an approved drug • Peer-reviewed articles in a scientific or medical journal considered "scientifically sound." 

Social Media and Health Care Professionals: Benefits

INTRODUCTION. Many social media tools are available for health care professionals (HCPs), including social networking platforms, blogs, microblogs, wikis, media-sharing sites, and virtual reality and gaming environments. 1 – 8 These tools can be used to improve or enhance professional networking and education, organizational promotion, patient care, patient …