Hogan Lovells Digital Health brochure 2024 - Flipbook - Page 15
We understand specialized strategies that
can expedite the FDA approval and EU CE
marking processes, streamline how much
data is needed for approval to be granted,
and successfully launch products to ensure
continuing compliance. After approval, we
work with you to commercialize products
successfully, addressing issues related
to: launch preparation, advertising and
promotion, and compliance; managing
regulatory inspections; coverage,
reimbursement, and pricing; patient
privacy; and careful use of intellectual
property and regulatory exclusivities to
manage product lifecycles.
We also assist on postmarket issues
relating to advertising and promotion,
recalls, and adverse event reporting.
This postmarket work extends to
assisting companies that face FDA,
DOJ, HHS, and state enforcement
actions, which may include
seizure, injunctions, civil penalties
proceedings, and criminal prosecution.
The 昀椀rm’s regulatory attorneys partner
with our white collar and litigation
teams to assist our clients in the most
sensitive enforcement actions faced by
the medical device industry.
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