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Articles

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

Experts Reveal Ebola Vaccine Status and Potential

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

FDA is Not Playing Games with Biosimilars

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.


Submitting Extractables and Leachables Data to Regulators

Claire Hill is solutions support manager at IDBS.

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming. 

Continued Process Verification and the Drive to Digitize the Process Validation Lifecycle

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Be Quick, But Don’t Hurry

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

Seeking Regulatory Advice

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Outsourcing Analytical Methods

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.

Let the Learning Commence

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

FDA Moves to Overhaul New Drug Review Process

A skilled workforce is needed to deliver on technology’s promising medical advances. 

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