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FDA Overhauls Premarket Cybersecurity Guidance for Device Makers

USA - November 6 2018 On October 18, 2018, the Food and Drug Administration (“FDA”) released a draft update to its guidance on the “Content of Premarket Submissions for...

Gerard M. Stegmaier, Mildred Segura, David Krone, Wendell Bartnick, Maryanne C. Woo, Christopher M. Butler.


FDA to implement OIG suggestions on IoT cybersecurity

USA - October 24 2018 The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food and Drug Administration’s (FDA) policies...

Gerard M. Stegmaier, Mildred Segura, David Krone, Wendell Bartnick, Maryanne C. Woo, Christopher M. Butler.


FDA vows to update cybersecurity guidance following OIG report on IoT cybersecurity

USA - October 17 2018 In September 2018, the Office of the Inspector General (OIG) published a report of its findings following an examination of the Food and Drug...

Gerard M. Stegmaier, Mildred Segura, David Krone, Wendell Bartnick, Maryanne C. Woo, Christopher M. Butler.


New Jersey Regulation Caps Payments to Health Care Providers by Pharma Manufacturers

USA - February 7 2018 On January 16, 2018, New Jersey enacted a new regulation which regulates the payments and items of value that prescribers can accept from...

Betty Yan, Julia Lake, Wayne R. Janke, Katie C. Pawlitz.


House Panel Approves Off-Label Communication, OTC Monograph User Fee, Good Samaritan Health Professionals Bills

USA - January 23 2018 The House Energy and Commerce Health Subcommittee voted to approve the following health policy bills on January 18, 2017......

Debra A. McCurdy.