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FDA issues draft guidances regarding social media: handling misinformation and character space limits

USA - June 20 2014 On June 17, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents concerning the use of social media and internet...

Elaine Tseng, Christina M. Markus, Jessica Ringel, Marian Lee.

FDA releases revised draft guidance on the distribution of scientific and medical publications about unapproved uses: guidance clarifies prior guidance and addresses reference texts and clinical practice guidelines

USA - March 5 2014 On March 3, 2014, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled, "Distributing Scientific and Medical...

Elaine Tseng, Christina M. Markus, Joanne Chan, Marian Lee.

2013 year in review: CDRH promotion and marketing enforcement letters

USA - February 19 2014 In 2013, FDA's Center for Devices and Radiological Health (CDRH) made publicly available on its website a total of 22 promotion and marketing-...

Edward M. Basile, Elaine Tseng, Marian Lee, Gillian Russell.

Clinical trial regulation seeks uniformity across EU

European Union - February 19 2014 On Dec. 20, 2013, the General Secretariat of the Council of the European Union released the revised proposal for a regulation, the "Proposal for a...

Pulina Whitaker, Beverly H. Lorell, MD, Christina M. Markus, Michael Petty.

CMS delays Open Payments data submission deadline, announces registration process; requires manufacturers and GPOs to report “aggregate” data by March 31, 2014

USA - February 11 2014 On Friday, February 7, 2014, the Centers for Medicare and Medicaid Services (CMS) announced that Open Payments registration is scheduled to begin on...

Seth H. Lundy, Brian Bohnenkamp, Ami P. Patel, Terrence B Burek.