LSHC Horizons Brochure 2024 - Flipbook - Page 87
87
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United States
A new age of psychedelics
88
A regulatory paradigm shift for OTC drugs under the ACNU rule
89
Complex generics
90
Drug pricing as potential basis for Bayh-Dole march-in
91
Medicare and HCT/P skin substitute products: Uncertainty persists as the
Medicare agency eyes sweeping changes to coverage and reimbursement
92
Navigating listed chemicals compliance requirements
93
OIG’s General Compliance Program Guidance
94
Pediatric exclusivity and the Pediatric Research Equity Act
95
Pharmaceutical patents in an era of increasing interagency scrutiny: Trends,
cross-currents and policies at the cross-section
96
Responding to the discovery of controlled substances in your facility
97
State of affairs: Medical device licensing enforcement is on the rise!
98
Unpacking FDA’s new draft guidance on scientific information on
unapproved uses of approved products
99
U.S. cosmetics industry faces new facility registration and product
listing requirements
100
Increased scrutiny of the accelerated approval program
101
New approach to accelerated approval withdrawals in 2024
102
Spotlight on single-trial approvals
103
