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2013 Archive

  • January 2013
    The PDA Letter wishes a Happy New Year to our readers in the January issue. Learn more about proposed structural changes within CDER at the U.S. FDA as well as updates on earlier organizational changes at the Agency. Also, we cover key sessions from the October Microbiology conference.
  • February 2013
    In this month’s issue of the PDA Letter, we look at the role QbD can play in vaccine development in addition to showcasing the results of a survey of Vaccines Interest Group members on the topic. We also speak with PDA board member Lisa Skeens, PhD, on how networking and PDA involvement have helped her career.
  • March 2013
    Follow the Annual 2013 logo for information about the meeting; learn about the U.S. FDA’s perspective on drug shortages, plus responses from industry. Also, we interview Marty Nealey, VP, Hospira about his upcoming Annual Meeting talk on drug shortages.
  • April 2013
    In this month’s issue of the PDA Letter, we look at the how risk and statistics can be used as process validation tools to build robust processes and resolve variations. We also speak with Martin VanTrieste for his perspective on proposed U.S. FDA metrics to solve the drug shortage crisis. Also, check out our redesigned Tools for Success!
  • May 2013
    In this month’s issue of the PDA Letter, PDA member Winston Brown offers advice for strategizing your career path for the long-term. Plus, recruiter Mark Lanfear offers his perspective on hiring trends within pharmaceutical manufacturing.
  • June 2013
    In this month’s issue of the PDA Letter, Hank Rahe looks at EMA’s proposed guidelines on cytotoxic limits. Mark Sebree discusses BD’s plans to manufacture a new line of prefilled sterile injectables. Plus, this month’s infographic showcases key events in the history of sterile manufacturing.
  • July-August 2013
    Follow the logo for the 2013 PDA/FDA Joint Regulatory Conference to view content related to the meeting; learn how companies can effectively tackle a consent decree. Also, read an interview with Rick Friedman and Mahesh Ramanadham, both from the U.S. FDA, for a preview of the joint regulatory conference.
  • September 2013
    In this issue, the PDA Letter looks at Paul Gauthier’s lifecycle of an external manufacturing partnership. We also speak with four microbiology experts for their perspective on nonsterile product manufacturing. Also, this month’s infographic uses statistics from BioPlan Associates to showcase pharmaceutical manufacturing outsourcing trends in 2013.
  • October 2013
    In this issue, the PDA Letter explores the validation of disposable systems from the perspective of Katell Mignot. Using information from the upcoming single-use systems technical report, we showcase various steps in the development of a single-use system.
  • November-December 2013
    The PDA Letter interviews six individuals who’ve worked on both sides of the industry/regulatory divide in our “Crossover Moves” cover story. Plus, read reports about the 2013 PDA/FDA Joint Regulatory Conference from three members who attended the meeting. You can also view photos from the conference in this issue’s PDA Photostream.