FDA issues draft guidance on refuse to accept policy for 510(k)s *

USA - August 17 2012
On August 13, 2012, the Food and Drug Administration announced the availability of a draft guidance titled “Refuse to Accept Policy for 510(k)s”.

Co-authors: D. Kyle Sampson, Sheldon T. Bradshaw.

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FDA proposes unique device identification system for medical devices *

USA - July 11 2012
On July 3, 2012, the Food and Drug Administration (“FDA” or “Agency”) released a proposed rule requiring that most medical devices marketed in the United States carry a unique device identifier (“UDI”).

Co-authors: D. Kyle Sampson.

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FDA issues three draft guidances on biosimilar product development *

USA - February 15 2012
On February 9, 2012, the U.S. Food and Drug Administration issued three draft guidance documents to assist industry in developing biosimilar products.

Co-authors: Heather D. Bañuelos, Gary C. Messplay, Allison Reschovsky, Adele M.K. Gilpin.

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FDA requests comments on draft guidance on responding to unsolicited requests for off-label information, and on certain other policies regarding off-label and pre-approval promotion *

USA - December 29 2011
In two separate announcements, the Food and Drug Administration is requesting (1) comments and suggestions regarding a draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices and (2) comments and information regarding scientific exchange related to both off-label promotion and pre-approval promotion of drugs and medical devices.

Co-authors: D. Kyle Sampson.

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CMS releases proposed Physician Payments Sunshine Rule *

USA - December 16 2011
The Centers for Medicare & Medicaid Services (“CMS” or “Agency”) released on December 14, 2011, its long-awaited proposed rule to implement the Physician Payments Sunshine Act (“Act”).

Co-authors: D. Kyle Sampson.

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