2016 Clinical Pharmacology Regulations Small Molecule 
Drug Target Review
JULY 4, 2023
These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. 3D rendering of Antibody Drug Conjugate Molecules.
Agency IQ
FEBRUARY 23, 2024
Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017.
Agency IQ
DECEMBER 11, 2023
Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more.
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