PDA Letter

July/August PDA Letter

Podcast

The July PDA Letter podcast is now available! Hear Hospira’s Sumant Ramachandra and Sandoz’s Joerg Windisch discuss biosimilars in part I and part II of the podcast.

Listen to our previous podcast archive

  • Maintain Your Client/CMO Relationship in Sickness and Health

    by Karen Ginsbury, PCI Consulting | Jul 07, 2015
    Maintaining a relationship, be it friendship, marriage or otherwise, requires hard work and open communication between two individuals to be successful. Personal relationships also face numerous challenges, and, at times, can be severed by both parties for a myriad of reasons.
    Full story
  • Patient Wants Should Drive Prefilled Syringe Design

    by Walter Morris, PDA | Jul 07, 2015
    An unused drug is an ineffective drug, no matter how much it cost to develop, manufacture and administer. The late U.S. Surgeon General C. Everett Koop offered a simpler observation: “Drugs don’t work in patients who don’t take them.”
    Full story
  • FDASIA: Three Years of Success

    by Rensi Sutaria, Banner Life Sciences | Jul 07, 2015
    It has been three years since the Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted. This Act expands the U.S. FDA’s authorities and strengthens its ability to safeguard and advance public health by giving it the power to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; promote innovation to speed patient access to safe and effective products; increase stakeholder involvement in FDA processes; and more. FDA has established a three-year implementation plan to help the public track the progress of these, and other provisions, established under FDASIA. As the three-year anniversary approaches, it presents a critical milestone to evaluating the success of this multifaceted law.
    Full story

Read the Full July/August Issue (Members Only)

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?

Science

Patient Wants Should Drive Prefilled Syringe Design
Walter Morris, PDA

Driving PAC Efficiency and Embracing New Technology
Lisa Skeens, Hospira

A Regulatory Perspective on Breakthrough Therapies
Rebecca Stauffer, PDA

Vaccines: An Ages Old Industry Faces Modern Challenges
John Finkbohner, MedImmune-AstraZeneca

Visible Particulate Detection Finally Emerging from the Fog
Roy Cherris, Bridge Associates International

Features

FDASIA: Three Years of Success
Rensi Sutaria, Banner Life Sciences

FDASIA and its Impact on Global Drug Supply
Dipti Gulati, PhD, PJI Biotech

Analyzing FDASIA’s Progress Since 2012
Jeffrey Broadfoot, Emergent BioSolutions

Continuous Manufacturing Success Lies in New Technologies, Integration and Education
Rebecca Stauffer, PDA

InfoGraphic: The ABCs of the PDA/FDA Joint Regulatory Conference

Regulation

Maintain Your Client/CMO Relationship in Sickness and Health
Karen Ginsbury, PCI

Quality Metrics: Drive Results with a Valuable Program
Steven Mendivil, Amgen, and Russell Wesdyk, U.S. FDA

Are All Employees Rewarded for Good Quality?
Jennifer Magnani, Sanofi Pasteur, and Anders Vinther, PhD, Sanofi Pasteur