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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