PDA Letter

November December PDA Letter

Podcast

Our October podcast is now available! Listen to Amgen's Madhu Balachandran discuss the future of manufacturing.

Listen to our previous podcast archive

  • Keeping the Signals Clear: Industry and FDA Collaborate on Innovation

    by Geetha Jayan, PhD, CDRH, U.S. FDA and Erin O’Brien, West | Oct 31, 2014
    The PDA/FDA Joint Regulatory Conference offers a chance for regulators and members of industry to share information and discuss the pressing issues of the day. This year, two attendees—one with the U.S. FDA and the other with a pharmaceutical company—took the time to share their insights of the conference. Not surprisingly, both noted the spirit of collaboration that marked this year’s joint regulatory conference.
    Full story
  • The Forecast for Global RIM is Cloudy

    by John Lawrie, Veeva Systems | Oct 31, 2014
    The life sciences industry is faced with a conundrum. Now serving a global marketplace, it must meet all local regulations while also continuing to improve efficiencies and speed to market. As a result, the industry has engaged affiliates and remote, external distributors throughout the world to expand its footprint while maintaining needed flexibility to weather economic trends.
    Full story
  • Exciting Technological and Scientific Advances Drive Prefilled Syringe Market

    by Walter Morris, PDA | Oct 31, 2014
    The first question that popped into my mind when I arrived in Huntington Beach, Calif. on October 5 was, What is so big about the Universe of Prefilled Syringes? I mean, we are talking about injectable technology, which has been around for hundreds of years. Really, what would possess almost 1000 people to congregate at this PDA event year after year for nearly a decade?
    Full story

Read the Full November December Issue (Members Only)

The PDA/FDA Joint Regulatory Conference is an opportunity for industry and regulators to come together and discuss the pertinent issues affecting industry as well as the latest developments in innovative medical products. In this issue, the U.S. FDA’s Geetha Jayan and West’s Erin O’Brien write about this year’s conference. In addition, we include an interview with Amgen’s Madhu Balachandran on his company’s efforts on next generation manufacturing, including modular facilities. Plus, editor Walter Morris writes about how injectables and medical devices are going mobile.