Showing posts with label Hamburg. Show all posts
Showing posts with label Hamburg. Show all posts

Thursday, October 2, 2014

Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov

Read the full article: Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov:

"This Strategic Priorities document articulates the goals and priorities that guide our Agency. It creates a framework that will allow us to integrate and achieve our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

While the priorities are individually important, they are also interconnected and cannot be addressed in isolation. Thus, for example, regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities. The cross-cutting nature of this plan will help FDA achieve the greatest benefits.

This document also sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to – and making better informed decisions about – the products FDA regulates. It describes in detail key strategies to help the Agency fulfill its public health mission."

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Friday, September 12, 2014

FDA could be source of innovation, Hamburg says - Denver Business Journal


Read the full article: FDA could be source of innovation, Hamburg says - Denver Business Journal:

"The FDA, in the course of approving new drugs and devices and overseeing their safety and effectiveness, gains broad knowledge of what companies are doing, what researchers are discovering about disease and how that relates to medical outcomes.

Hamburg’s vision is for the FDA to use that position to help researchers and companies make more effective new treatments and prove new medical advances more quickly, she said.

“We have a lot more to offer than has historically been appreciated,” said Hamburg, U.S. Commissioner of Food and Drugs since 2009. “The regulator has a very different role than the innovator or the academic researcher, but we can be a very effective partner for both.”"

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Tuesday, December 3, 2013

FDA aims to oversee drug compounders - USA Today


FDA aims to oversee drug compounders - USA Today:

""We will be encouraging health care providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities," FDA Commissioner Margaret Hamburg says. "This will be a critical step they can take to better assure the health and safety of their patients."

Outsourcing facilities will also be required to report specific information about the products they compound, including a list of all the products compounded during the previous six months, and details about the source of the active ingredient, as well a report known as adverse effects."

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