Michael Causey’s picture

By: Michael Causey

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San Jose, California. Shuren’s presentation was one of several sessions of particular interest to life sciences shops.

Erwin Miller’s picture

By: Erwin Miller

The Federal Drug Administration’s (FDA) mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since the fall in 2015 to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to take science- and risk-based actions to help prevent the contamination that leads to food-borne illness.

Jon Speer’s picture

By: Jon Speer

Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.

Howard Sklamberg’s picture

By: Howard Sklamberg

Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

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).

Syndicate content