FDA - CDRH 2011 Strategic Priorities

Another post on what you can expect in 2011.

The FDA's CDRH (Center for Devices and Radiological Health) published the broad strategies that they will implement in 2011 in alignment with four priority areas. It includes timeframes associated with each strategy, and specific actions they will take to meet those goals or make significant progress in 2011 achieving those goals.

The 4 priority areas are:

1. Priority 1. Fully Implement a Total Product Life Cycle Approach
2. Priority 2. Enhance Communication and Transparency
3. Priority 3. Strengthen Our Workforce and Workplace
4. Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs

Source:   FDA - CDRH 2011 Strategic Priorities

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Related articles

• "FDA Releases Plan Intended to Improve the 510(k) Program; Plan Contains 25 Action Items to Implement During 2011" and related posts (fdalawblog.net)
• New FDA 510(k) medical device regulations coming Wednesday (medcitynews.com)
• FDA Revamps Medical Device Approval (informationweek.com)
• "Shocking! - Over 28,000 Reports Of External Defibrillator Problems In Five Years, Says FDA" and related posts (pharmagossip.blogspot.com)
• FDA medical device complaints up, but disputes were down (medcitynews.com)

Our Mobile Optimized Blog Re-Launched

I'm stoked!  I just finished refreshing the mobile optimized version of this blog.

Check it out in one of two ways:

1. Follow this url:  http://drughealth.prohost.mobi/
2. Follow the QR code provided in this post

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Future Pills - Drugs, Devices, and More

An interesting intersection of drugs and medical devices, reported in this LA Times article, Smarter Pills - BEEP! BEEP! BEEP! This is your medicine. It's time for another dose.

In a nutshell,

"The goal: new devices to help people take their meds on time and improve the results coming out of clinical trials for new drugs."

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Related articles

• Novartis readies first smart pill app (fiercebiotech.com)
• Manufacturing Defects in Medical Device (online.wsj.com)
• Placebos can work even when you know they're fakes (newscientist.com)

Learn From 2010 FDA Warnings To Pharma Companies

2010 is now behind us.  It's time to turn your attention to 2011. If you're in the FDA GMP training space, consider leveraging the following resource in your GMP trainings:  FDA Inspections, Compliance, Enforcement, and Criminal Investigations - Warning Letters.

From this main Warning Letters page, you can research and learn from the warning letters, that can be found by:

• Year
• Company
• Subject
• . . . and many other advanced search criteria

The Warning Letters can be used as great examples of just how important it is to comply with the regulations.

You might also be interested in:
Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

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Related articles

• FDA Warns Public of Continued Extortion Scam by FDA Impersonators (nlm.nih.gov)
• Invisalign 'Invisible Braces' Maker Gets FDA Warning (webmd.com)

Avoid Slips, Trips, and Falls

Someone in our household, who shall remain nameless, has fallen off a ladder a few times and broken bones.
In the spirit of preventing injuries, I share this wonderful resource:  

• Slip, Trip, and Fall Prevention for Healthcare Workers - Website
• Slip, Trip, and Fall Prevention for Healthcare Workers - PDF

Don't Stop Reading !!! 

Even though this mentions "Healthcare Workers," there's great stuff that's applicable to anybody's home.

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Related articles

• New guidelines for preventing falls in the elderly include: start tai chi, cut-back on meds (scienceblog.com)
• Tai Chi May Boost Balance in Seniors (webmd.com)
• Falls as Serious for Elderly as Stroke, Heart Attack (nlm.nih.gov)

FDA Launches Website Explaining Food and Drug Regulations

It's a new year, and it's time to think about professional development goals for 2011.  You or your friends, family, or staff, might want to consider learning some of these FDA Basics:

FDA Basics for Industry  or
FDA Basics - Provides Information About FDA and What the Agency Does

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Related articles

• FDA Defends Decision on Avastin (online.wsj.com)
• "FDA Launches Website To Help Regulated Industries Save Time, Resources" and related posts (drugs.com)

Watch Out For CEP Problems in 2011

Image via WikipediaThe European Directorate for the Quality of Medicines and Healthcare (EDQM) suspended or withdrew 19 certificates for active pharmaceutical ingredients in the latter half of 2010 because their manufacturers failed or refused inspections*. These are the main points:

1. Virtually all of the suppliers included in the list was from Asia.
2. The EDQM awards a CEP if the company declares GMP compliance (without a pre-approval inspection).
3. The EDQM conducts periodic inspections of API manufacturers, however, the EDQM has inspection capacity constraints and can only inspect about 30 sites a year.

This is important to follow, as you can expect the huge number of API suppliers to continue to come from that part of the world,

Acronyms:
-  Certificates of Suitability (CEPs)
-  Active pharmaceutical ingredient (API)

* SecuringPharma - EDQM suspends, withdraws 19 API certificates in 2H10

You might also be interested in:
Active Pharmaceutical Ingredients, Second Edition: Development, Manufacturing, and Regulation (Kindle edition)

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Related articles

• Huber Receives Approval to Produce Active Pharmaceutical Ingredients (eon.businesswire.com)
• B. Braun Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API) (fda.gov)

FDA Dietary Supplement Guidance for Small Businesses

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The FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in the DS CGMP rule (21 CFR part 111). The DS CGMP rule is binding and has the full force and effect of law:

FDA: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide

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Related articles

• "FDA Launches Website To Help Regulated Industries Save Time, Resources" and related posts (drugs.com)
• FDA Targets Tainted Dietary Supplements (webmd.com)
• Practice Safety With Dietary Supplements (everydayhealth.com)
• Tainted Products Marketed as Dietary Supplements (nlm.nih.gov)
• Many Dietary Supplements Tainted With Prescription Compounds, Says FDA (medicalnewstoday.com)
• FDA Releases CGMP Guidance For Small Business (medicalnewstoday.com)

Pharma Jargon Buster

Here's a nifty reference to add to your bookmarked favorites relating to pharma, biopharm, medical device, dietary supplements, and more.

NSF-DBA's Jargon Buster, lists abbreviations and acronyms, with their associated meanings.

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Related articles

• Academic Jargon: Field-Specific Insults (r-bloggers.com)
• Daily Blogwatch: Worst Business Jargon of 2010 (dailyfinance.com)
• Pensions jargon explained (telegraph.co.uk)
• Jargon Watch: Acronyms Every Green Urbanist Should Know (treehugger.com)

Parents - Are Your Kids Using Drugs?

Image via WikipediaParents and adult caregivers, if you're not sure, there's a website that can provide you with the tools needed to raise drug-free kids:


Parents. The Anti-Drug.


There's a tremendous wealth of information offered by the site.


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Related articles

• "Red Ribbon Week: Talk To Your Child AboutĀ Drugs" and related posts (blogs.babble.com)
• The Partnership for a Drug-Free America Announces Name Change to The Partnership at Drugfree.org (eon.businesswire.com)

2011 Predictions - Congress and FDA-Regulated Industries

Find out the answer on FDA Matters: The Grossman FDA Report (TM) - - - Will the New Congress Be Good for FDA-Regulated Industries?

Wishing you all the best in 2011!

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Related articles

• FDA Regulation of Mobile Health, State of Wireless Health Industry Among Popular Themes Explored at 2nd Annual Digital Health Summit (prnewswire.com)
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