Scientific-exchange-vs-promotion

Scientific Exchange: Grey Areas and Best Practices

Fdli.orgOct 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

https://www.fdli.org/wp-content/uploads/2019/10/11-12-Scientific-Exchange-1.pdf 

OffLabel Promotion Or Scientific Exchange A Multimillion

Meddeviceonline.comJul 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

https://www.meddeviceonline.com/doc/off-label-promotion-or-scientific-exchange-a-multimillion-dollar-question-0001 

Scientific Exchange of Information Differs From Promotion

Fdanews.comJan 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 …

https://www.fdanews.com/articles/114143-scientific-exchange-of-information-differs-from-promotion 

Scientific Exchange of Information Versus Promotion | FDAnews

Fdanews.comMay 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.

https://www.fdanews.com/articles/106561-scientific-exchange-of-information-versus-promotion 

Scientific Exchange: What Every Compliance Officer Should

Ehcca.comOct 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

http://www.ehcca.com/presentations/pharmacongress16/helman_pc1.pdf 

Drug Promotion and Scientific Exchange — The Role of …

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

https://www.nejm.org/doi/full/10.1056/NEJM199107183250310 

Dissemination of Clinical Trial Information: It’s a Fine

Media.agg.comScientific 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

https://media.agg.com/files/event/c933355c-7a5f-41b8-b19c-60ffbcdf5468/presentation/eventattachment/fea69dc7-d799-484b-857e-e8ba5b34b260/minsk_disseminationofclinicaltrailinformation.pdf 

Scientific Exchange/Safe Harbor | BIO

Bio.orgScientific 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 …

https://www.bio.org/courses/scientific-exchangesafe-harbor 

FDA Regulation of Pharmaceutical Marketing

Ehcca.com– 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."

http://www.ehcca.com/presentations/fdasymposium3/casola_1.pdf 

Social Media and Health Care Professionals: Benefits

Ncbi.nlm.nih.govINTRODUCTION. 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 …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4103576/