Publications
Writing for the record
Peer-reviewed work, regulatory contributions, and book chapters. Most of what I publish is for practitioners who need answers the textbook does not have yet.
Book Chapters
- 2026
Regulatory Strategy for Digital Therapeutics and Artificial Intelligence-Enabled Devices
Parks A, Butt N, Farcas S, Johnson AN. ICLG – Digital Health Laws and Regulations 2026 (Ch. 5), Global Legal Group.
Chapter covering regulatory pathways for digital therapeutics and AI/ML-enabled medical devices across global jurisdictions, including FDA's predetermined change control plans and EU AI Act intersections with MDR.
- 2019
Regulating Cell & Gene Therapies, Genetically Modified Cells and Devices in Regenerative Medicine
Johnson AN. US Regulatory Affairs Fundamentals (11th ed.), RAPS.
Foundational chapter on FDA's cell and gene therapy framework. Covers CBER pathways, combination products, and CMC requirements for regenerative medicine.
- 2017
Medical Device Clinical Testing and GCPs
Johnson AN. US Regulatory Affairs Fundamentals (10th ed.), RAPS.
Reference chapter on IDE pathways, GCP requirements for medical device studies, and FDA expectations for clinical evidence.
Peer-Reviewed Articles
- 2021
A Look at FDA's Gene and Cell Therapy Framework Launch in 2020
Johnson AN. Dateline Federation: Emerging Therapies Special Issue, 22(1).
Retrospective on FDA's January 2020 cell and gene therapy guidance package and early industry adoption signals.
- 2018
Virtual and Augmented Reality as Game-Changers in Anesthesiology
Johnson AN. Journal of Anesthesia & Intensive Care Medicine, 5(1): 555652.
Review of XR applications in perioperative training and procedural guidance, with regulatory considerations for SaMD classification.
- 2017
Synthetic MRI for Clinical Neuroimaging: Results of the MAGnetic Resonance Image Compilation Prospective Trial
Tanenbaum L, Tsiouris AJ, Johnson AN, et al.. American Journal of Neuroradiology, 38(6): 1103-1110. doi: 10.3174/ajnr.A5227
Prospective multi-site trial validating synthetic MRI image generation against conventional sequences. Won the 2017 Lucien Levy Award for Best Original Research Article from AJNR.
RAPS Regulatory Focus
- 2017
Harmonization of Gene Therapy Regulation
Johnson AN. Regulatory Focus (RAPS).
Cross-jurisdictional comparison of FDA, EMA, and PMDA frameworks for cell and gene therapy products.
- 2017
Small Organizations, Big Regulatory Strategy
Johnson AN. Regulatory Focus (RAPS).
Strategic guidance for early-stage and VC-backed medtech and biotech companies building lean regulatory functions from scratch.
Conference Abstracts
-
2023Quantifying Challenges to Development of Generics and Biosimilars in Non-Hodgkin's Lymphoma Therapeutics
Johnson AN, Fulgoni A, Wang L, et al.. Blood, 142(Suppl 1), Abstract 5148 — ASH Annual Meeting.
Mixed-methods analysis of barriers to biosimilar and generic entry across non-Hodgkin's lymphoma therapeutic classes. Presented at the 2023 ASH Annual Meeting.
Full CV available on request. See the press kit for downloadable bio.