Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper von Cocchetto, David M., Stotka, Jennifer L., Zezza, Diane, Hassall, Thomas H., Brophy, Gregory, Peterson, Donna

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Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper von Cocchetto, David M., Hassall, Thomas H., Carter, Linda, Cutt, John R., Rogalski-Salter, Taryn, Schumaker, Cathie, Stotka, Jennifer L.

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Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels von McCune, Susan K., Mathis, Lisa L., Cocchetto, David M., Ball, Karen, Rodriguez, W.

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The Food and Drug Administration'S Fast Track Designation: Observations from the Initial Two Years of this Designation von Cocchetto, David M.

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A Comparison of Salmeterol with Albuterol in the Treatment of Mild-to-Moderate Asthma von Pearlman, David S, Chervinsky, Paul, LaForce, Craig, Seltzer, James M, Southern, D. Loren, Kemp, James P, Dockhorn, Robert J, Grossman, Jay, Liddle, Roger F, Yancey, Steven W, Cocchetto, David M, Alexander, W. James, van As, Andre

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A Tribute to Mr. Thomas W. Teal on His Retirement von Cocchetto, David M., Croswell, Roger W.

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Guest Editors' Note: Special Issue on Regulatory Affairs von Cocchetto, David M, Miller, Loren L., Croswell, Roger

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The Evolving Paradigm for Clinical Development and Regulatory Approval of Antiretroviral Drugs in the United States von Cocchetto, David M., Smiley, Lynn

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Protein binding as a primary determinant of the clinical pharmacokinetic properties of non-steroidal anti-inflammatory drugs von LIN, J. H, COCCHETTO, D. M, DUGGAN, D. E

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Faster Access to Drugs for Serious or Life-Threatening Illnesses through use of the Accelerated Approval Regulation in the United States von Cocchetto, David M., Jones, Douglas R.

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Understanding the Interfaces among Multiple Technical Disciplines: An Increasing Challenge for Regulatory Affairs von Cocchetto, David M.

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Methods for Vascular Access and Collection of Body Fluids from the Laboratory Rat von Cocchetto, David M., Bjornsson, Thorir D.

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The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process von Miller, Loren L., Cocchetto, David M.

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A Review of Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials von Cocchetto, David M.

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Regulatory Decision-Making in the United States Based on a Single Pivotal Clinical Study: Principles and Precedents von Cocchetto, David M.

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Hemodialysis Using Prostacyclin Instead of Heparin as the Sole Antithrombotic Agent von Zusman, Randall M, Rubin, Robert H, Cato, Allen E, Cocchetto, David M, Crow, James W, Tolkoff-Rubin, Nina

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Erratum to: Safer, Better, More Appropriate: Clinical Trial Design for Pediatric Drug Labels von McCune, Susan K., Mathis, Lisa L., Cocchetto, David M., Ball, Karen, Rodriguez, W.

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Behavioral perturbations in the vitamin K-deficient rat von Cocchetto, David M., Miller, Diane B., Miller, Loren L., Bjornsson, Thorir D.

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Can Regulatory Affairs Personnel Add Value When the Goal is Increasing Speed of Drug Development? von Cocchetto, David M.

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Paradoxical Bronchospasm After Use of Inhalation Aerosols: A Review of the Literature von Cocchetto, David M., Sykes, R. Scott, Spector, Sheldon

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