Life Sciences Horizons Brochure 2025 - Flipbook - Page 108
2025 Horizons Life Sciences and Health Care
United States
.
107
12
Click on a section to take you to the relevant page
108 A new regulatory frontier for precision
118
FDA offers new way for nonprescription
drugs to be marketed
119
BIOSECURE stalled in 2024, but may
resurface
diagnostics in the trump administration
109 New scrutiny for pharmaceutical market
access innovations
110 The evolving biosimilar framework: Moving
toward interchangeability and less clinical data
111
Accelerated approval: FDA defines whether
a confirmatory trial is “underway”
112
Scaling back: Changes to FDA’s pediatric drug
development incentives
113
The promise of RWD/RWE to continue to fine
tune REMS
114
Increasing state board enforcement against
device firms, and the role of the DSCSA
116
Psychedelics: Has FDA missed its opportunity
and allowed the states to open the door?
117
Unpredictability persists in DEA quota system
