Showing posts with label initiative. Show all posts
Showing posts with label initiative. Show all posts

Tuesday, April 24, 2012

FDA Global Initiative

Updated June 30, 2024


The original links broke.

You might also like:

---  the original post follows below  ---

FDA’s success in protecting the U.S. public depends increasingly on its ability to reach beyond U.S. borders and engage with its government regulatory counterparts in other nations, as well as industry and regional and international organizations, to help ensure the quality and safety of products before they reach the United States.
Through effective global engagement, FDA is working with its many international partners to weave a global safety net that benefits public health in the United States and around the world.
  • Report: Global Engagement (PDF - 5 MB)

FDA Global Initiative: 


"Global production of FDA-regulated products has quadrupled over the last decade and continues to grow.  Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities.


Almost 40 percent of the fruits and nuts and 85 percent of the seafood consumed in America comes from abroad.  Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. The growth in imports has been rapid and promises to accelerate.


Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission.  Over the next decade, FDA will transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment."

'via Blog this'

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Tuesday, November 30, 2010

FDA Home Use Device Initiative


On the Designated Representative and Exemptee Blog - News On FDA Home Use Device Initiative: the FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device.

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Wednesday, January 27, 2010

FDA CDRH Announces Strategic Initiatives

Updated Dec 7, 2015:
The link in the original post went stale. You might be interested in:
FDA CDRH Strategic Priorities and Updates

- - - -  original post follows below - - - -

There's a lot here. I recommend you view this or download the FDA PDF, CDRH FY 2010 Strategic Priorities.

Here's what you'll find:

Executive Summary
Priority 1. Fully Implement a Total Product Life Cycle Approach
Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
Strategy 1.2. Improve Guidance and Regulation Development
Strategy 1.3. Develop a Cross-Center Compliance Strategy
Priority 2. Enhance Communication and Transparency
Strategy 2.1. Develop a Strategic Approach to Public Communication
Strategy 2.2. Improve Internal Communications
Strategy 2.3. Increase Transparency in Decision Making
Priority 3. Strengthen Our Workforce and Workplace
Strategy 3.1. Recruit, Develop, and Retain High-Quality Employees
Strategy 3.2. Leverage External Expertise
Strategy 3.3. Establish Pathways for Resolving Differences of Opinion
Strategy 3.4. Improve Internal Administrative Processes
Strategy 3.5. Make CDRH's White Oak Facilities More Workplace-Friendly
Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
Strategy 4.1. Foster Development of Medical Devices to Respond to Unmet Public Health Needs
Strategy 4.2. Develop a Personalized Medicine Program

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Saturday, March 14, 2009

NIH NIAAA Wants Re-Thinking Drinking (video)

Take some advice from these testimonials:

  • "Sometimes we do things out of habit and we don't really stop to think about it. This made me think about my choices."
  • "It emphasized that drinking is not bad in and of itself—it's how much you're doing it and how it's affecting your life."
  • "I thought the strategies for cutting down were really good. It gives you tools to help yourself."

Learn more about the NIH & NIAAA's new initiative to help rethink drinking, "Rethinking Drinking - Alcohol and your health. The website is pretty robust and easy to use.

  • Download the free brochure: Rethinking Drinking - Alcohol and your health (pdf)
  • The site features interactive tools, such as calculators for measuring alcohol calories and drink sizes. NIAAA is part of the National Institutes of Health. "About 3 in 10 U.S. adults drink at levels that elevate their risk for alcoholism, liver disease, and a diverse array of other physical, mental health, and social problems. Yet, many people give little thought to their drinking habits and the attendant risks" notes NIH Acting Director Raynard S. Kington, M.D. "These new materials remind all of us to think about how alcohol may be affecting our health"

If you don't have time to check out the website, listen to this ABC News video to learn more, "Do you drink too much? A new government initiative to help you rethink your drinking" (video)"

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Wednesday, November 19, 2008

Quality by Design (QbD) For Analytical Methods (video)

Updated 3/10/2020:

This topic is seriously out of date.  This thread started in 2008.

You might also be interested in this FDA slide presentation from 2011:
Quality by Design Approaches to Analytical Methods -- FDA Perspective

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Updated 8/10/2016:

You might also be interested in this blog post:
FDA Doubles Down on QbD (BioProcess Blog)

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Updated 6/25/2015:

This post didn't age well, the links in the original post are no longer found.

You might also be interested in:   QbD Considerations for Analytical Methods - FDA Perspective

=========  original post below =========

Maribel Ross, Senior Editor with Pharmaceutical Technology, discusses the FDA's quality by design (QbD) initiative as it applies to analytical methods with one of the top experts in this area, Dr. Moheb Nasr, Director of FDA's Office of New Drug Quality Assessment, in this PharmTech TV video, "Live From 2008 AAPS: Analytical Methods for QbD."

#FDA #GMP #training #cGMP

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