Multiple Authors
By: Rachel E. Sherman, Robert M. Califf

In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a system.

Taran March @ Quality Digest’s picture

By: Taran March @ Quality Digest


They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.

What are they? Pharmaceutical brand names like Advil, Zantac, Lipitor, and Xolair. Azor, Exelon, Zostavax, and Chantix. Gardasil, Cubicin, Levemir, and Sensipar.

Multiple Authors
By: Rachel E. Sherman, Robert M. Califf

Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations surrounding this evidence base.

NIST’s picture

By: NIST

I

n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics useless, and that few replacement drugs are in the pipeline. But help may be on the way.

Peter Marks’s picture

By: Peter Marks

Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the center as the preeminent regulatory organization for biologics. One way CBER is achieving this is through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines Research and Review (OVRR).

By: Michael Kopcha

The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages.

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