FDA Establishes Docket on Patient Participation in Medical Product Discussions
In the November 4, 2014, Federal Register, FDA announced a public docket for comments on Patient Participation in Medical Product Discussions under FDASIA. FDA seeks input from stakeholders on how to obtain the views of patients during the medical product development process and ways to consider patients' perspectives during regulatory discussions.

FDA Withdraws Approval of 14 NDAs for Failure to File Annual Reports
In the November 17, 2014, Federal Register, FDA withdrew approval of 14 new drug applications ("NDAs") for the multiple holders' repeated failure to file the required annual reports for the applications.

FDA Proposes Order to Reclassify Rigid Pedicle Screw Systems
In the November 12, 2014, Federal Register, FDA proposed to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls) via an administrative order, citing FDASIA Section 608(b) as the authority for not proposing such a change through notice and comment rulemaking. In the notice, FDA also proposed to require the filing of a premarket approval application or a notice of completion of a product development protocol for the dynamic stabilization systems, currently a subtype of pedicle screws, regardless of the indication for use. It also proposed to require clarification of the device identification of pedicle screw spinal systems, to more clearly delineate between rigid pedicle screw systems and dynamic stabilization systems.

FDA Issues Order Debarring Armando Santos for 12 Years
In the November 10, 2014, Federal Register, FDA issued an order debarring Armando Santos from providing services to any person who has an approved or pending drug product application for 12 years. FDA cited Mr. Santos's conviction on seven felony counts for federal health care offenses, including health care fraud and false statements.

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