Including

• Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

  Adverse Events Monitoring, Pharmacovigilance and Risk Management - March 2015
  by Katharine R. Latimer, Partner at Hollingsworth LLP (Washington, DC), Linda Pissott Reig, Shareholder at Buchanan Ingersoll & Rooney PC

• Using FDA’s Citizen Petition Process and Litigation to Achieve Market Success

  Using FDA’s Citizen Petition Process and Litigation to Achieve Market Success - March 2015
  by Chad A. Landmon, Partner at Axinn Veltrop & Harkrider LLP

• Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns

  Classification and the Essentials of the Device Premarket Review Process A - March 2015
  by Seth A. Mailhot, Partner at Michael Best & Friedrich LLP (Washington, DC)

• cGMPs: Drugs and Biologics (current Good Manufacturing Practices)

  Current Good Manufacturing Practices: Drugs and Biologics A - March 2015
  by Kirsten Mayer, Partner at Ropes & Gray LLP (Boston, MA)

• The Drug Supply Chain Security Act – Summarizing the Act and Its Effect on FDA Practice

  The Drug Supply Chain Security Act Summarizing the Act and Its Effect - March 2015
  by Michael Walsh, Principal and International Managing Partner at Midgard Consulting Inc.

• Part 2 – Hatch-Waxman and BPCIA Overview

  Hatch-Waxman and BPCIA Overview - March 2015
  by Kurt R. Karst, Director at Hyman, Phelps & McNamara, P.C., Christopher E. Jeffers Ph.D., Member at Mintz Levin Cohn Ferris Glovsky and Popeo PC

• Drugs and Biologics: Labeling

  Drugs and Biologics: Labeling A - March 2015
  by Alan G. Minsk, Partner at Arnall Golden Gregory LLP

• Part 1 – Patents, Trademarks and Other IP Protections and Mechanisms

  Part 1 –Patent Protection for Drugs and Biologics - March 2015
  by Jill K. MacAlpine, Ph.D., Partner at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC), Donna M. Meuth, Associate General Counsel, Intellectual Property at Eisai Inc. (Andover, MA)

• Understanding the Clinical Trial Process for Drugs and Biologics

  Understanding the Clinical Trial Process for Drugs and Biologics A - March 2015
  by Daniel A. Kracov, Partner at Arnold & Porter LLP