Michael L Lanthier

Regulatory watch: Innovation in biologic new molecular entities: 1986–2014

K. Miller, Michael L Lanthier, 2015, Nature Reviews Drug Discovery.

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.

Khaled Bouri, Rachel E. Sherman, Michael L Lanthier, 2014, JAMA.

Accelerated approval and oncology drug development timelines.

Richard Pazdur, Robert Justice, Rajeshwari Sridhara, 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Investigating the landscape of US orphan product approvals

Michael L Lanthier, K. Miller, K. L. Miller, 2018, Orphanet Journal of Rare Diseases.

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals

G. D. Dal Pan, Michael L Lanthier, K. Miller, 2017, Drug Safety.

An Analysis of Antibacterial Drug Development Trends in the US, 1980 - 2019.

N. Mahoney, Michael L Lanthier, E. Cox, 2020, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.

J. Woodcock, Michael L Lanthier, K. Miller, 2013, Health affairs.

Trends In Orphan New Molecular Entities, 1983-2014: Half Were First In Class, And Rare Cancers Were The Most Frequent Target.

Michael L Lanthier, K. Miller, K. L. Miller, 2016, Health affairs.

Drug-review deadlines and safety problems.

R. Temple, Michael L Lanthier, C. Nardinelli, 2008, The New England journal of medicine.

Economic issues with follow-on protein products

Clark Nardinelli, Michael L Lanthier, R. Behrman, 2008, Nature Reviews Drug Discovery.

Riposte: FDA response to ‘Yin, yang and the biopharmaceutical industry’

J. Woodcock, J. L. Goodman, A. Rosenberg, 2003 .