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ISSUE NO. 8 — Bioanalytical Challenges Encountered when Developing ADA Assays

Mar 1, 2019
ISSUE NO. 7 — Understanding the Intrinsic and Extrinsic Factors that Alter Drug Exposure and Toxicity

Jan 1, 2019
ISSUE NO. 6 — Hybrid Medicines and 505(b)(2) NDA Approval Pathways — updated 2021

Dec 1, 2018
ISSUE NO. 4 — Key Considerations for Biosimilar Clinical Pharmacology Studies

Sep 1, 2018
ISSUE NO. 3 — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs — updated April 2022

Jun 1, 2018
ISSUE NO. 2 — Revolutionizing Traditional Medicine with Cannabis-based Medicinal Products

Feb 1, 2018
ISSUE NO. 1 — FDA Guidance Ensures New Drugs Are Studied for Their Potential to Impair Driving Ability

Dec 1, 2017