FDA Releases FSMA Strategy Document as a 'Springboard for Discussion' | Food Safety News

FDA Releases FSMA Strategy Document as a 'Springboard for Discussion' | Food Safety News:

"The document is meant “to guide the next phase of FSMA implementation by outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change.”

It includes plans for internal changes as well as changes to guides for implementing rules regarding food and feed facilities, produce safety and the new import system."

'via Blog this'

Read the FDA's strategy document:
Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA) - Protecting Public Health by Strategic Implementation of Prevention-Oriented Food Safety Standards 

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FDA Priorities For 2011-2015

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Updated February 2, 2021:

The U.S. Food and Drug Administration (FDA) today released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015, FDA’s “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century” - PRNewsWire.

It conveys the FDA's vision for the future, by mentioning:

• a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles
• an integrated global food safety system focused on prevention and improved nutrition
• expanded efforts to meet the needs of special populations.

The document is organized into four major sections:
1.0 Introduction 
2.0 Cross-Cutting Strategic Priorities
3.0 Strategic Goals and Long-Term Objectives
4.0 Implementation

You might also be interested in:
Strategic Priorities Blog posting by FDA Commissioner Margaret A. Hamburg

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FDA Promises Swift-Aggressive Enforcement To Protect Public Health

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The Food and Drug Administration (FDA) is articulating its enforcement strategy in order to ensure strategic alignment within the Agency and express why enforcement is critical to protecting public health. The FDA has the responsibility and authority to safeguard the public health and ensure compliance with the laws and regulations it administers pertaining to foods, drugs, medical devices, biologics, and tobacco products.

Enforcing the laws and regulations is one of the Agency’s highest priorities. The FDA is committed to swift, aggressive enforcement actions to protect the public health.

Under the FDA's scrutiny, it's important more than ever before that drug and device manufacturers have their house in order.  Getting a house in order also includes paying attention to executive and operator training around the FDA regulations, such as cGMP regulations and more.

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FDA CDRH Announces Strategic Initiatives

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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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HIV AIDS Update - Obama strategy and more (podcast)

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Listen to Ernest Hopkins, the San Francisco AIDS Foundation's Director of Federal Affairs, as he talks about the Obama administration's progress on the National AIDS Strategy, the recent White House reception with LGBT leaders on the 40th anniversary of the Stonewall riots and the progress being made toward lifting the US ban on HIV-positive foreign travelers, in this podcast, SFAF.org Podcast #58 - A Federal HIV/AIDS Update with Ernest Hopkins. 

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FDA GMP - Tips on Penicillin Drugs

Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

- -  original post follows below  - -
Here's a little refresher in the form of 4 questions, answered by the FDA, Questions and Answers on Good Manufacturing Practices Questions and Answers on Good Manufacturing Practices - Penicillin Drugs.

In a nutshell, all penicillin finished pharmaceutical manufacturers, including repackers, are required by the CGMP regulations to establish a comprehensive control strategy designed to prevent cross-contamination of other drugs with penicillin. These requirements include:

• 21 CFR 211.42(d): Separation of facility and equipment
• 21 CFR 211.46(d): Separate air handling systems (HVAC)
• 21 CFR 211.176: Test for traces of penicillin where possible exposure exits.

Related Posts:
2009 FDA Orange Book Online - Brand New 29th Edition
Easy FDA Orange Book Search Widget
About The FDA Orange Book - Slide Deck (free)
FDA Orange Book - Online

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FDA - Preparation Tips For Meetings With The FDA

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If you have upcoming meetings with the FDA, or are looking for ways to be more effective during the meeting, then this slide deck is a must read, Strategies to Prepare for Meetings with the FDA by Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA (circa 2006). In summary, she highlights these 3 things:

• Meetings Are a Critical Component of the Way We (Industry and FDA) Do Business
• Extensive Framework Around Meeting Process and Procedures Enhance Predictability
• Efficient Use of Meetings Facilitates Our Shared Public Health Goal

Related Posts: FDA Guidance - FDA and Sponsor-Applicant Meetings

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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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FDA - Focus On Opioid Manufacturer REMS FDAAA

Updated September 15, 2016

The original post didn't age well (broken links).

You might also be interested in:
Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)

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If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.

More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

Previous Posts:
Opiates Can Kill Kids!

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