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2015 Archive

  • January 2015
    The PDA Letter wishes a Happy New Year to our readers in this January issue. Learn about the control strategies for raw materials used for biologics from Annemarie Moeritz and recent pharmacopoeial updates from Europe on raw materials used for ATMP development from Rebecca Stauffer.
  • February 2015
    What is the future of manufacturing? Find out in the March issue of the PDA Letter! Robert Bowen discusses the state of continuous processing in the industry in the cover story and Rebecca Stauffer writes about flexible manufacturing. Robert Kieffer looks at how to build a culture of quality.
  • March 2015

    The U.S. FDA’s push for quality metrics continues to gain momentum. But what does this mean for the future state of pharma?

  • April 2015

    Data integrity issues have been cited in ever greater numbers by global regulators in both emerging and developed markets. How can companies develop a culture of ethics that prevents this from happening?

  • May 2015

    As the industry moves away from traditional models of manufacturing, having an effective technology transfer plan will be essential.

  • June 2015

    Sterile product manufacturing faces divergent expectations from both regulators and compendial guides. How can companies meet these disparate requirements satisfactorily?

  • July August 2015
    This July marks the third-year anniversary of FDASIA as well as deadlines for key U.S. FDA deliverables under the law. Has the Agency been able to meet the goals set forth by this groundbreaking legislation?
  • September 2015
    For years, microbial control methods, while sufficient, have not been pegged as state-of-the-art in the industry. But new solutions and methods have entered the market.
  • October 2015
    Learn about the mountains that biosimilar developers have to scale in order to develop their products from scientists Sumant Ramachandra and Joerg Windisch. This issue’s infographic offers a comparison of the approval process for biosimilars and innovator biologics. Also, check out articles promoting topics that will be highlighted at this year’s Universe of Pre-filled Syringes and Injection Devices meeting.
  • November December 2015
    Have you taken an extended break from your career in industry? Or are you still trying to your foot in the door many years after college? Enith Morillo discusses how those reentering the industry or overcoming a late start can develop a successful strategy to grow their careers in pharma. Rebecca Stauffer covers changes to the U.S. FDA’s inspection strategy based on talks at the 2015 PDA/FDA Joint Regulatory Conference. And speaking of the conference, check out photos from this exciting regulatory event!

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