Monday, January 31, 2011

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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Sunday, January 30, 2011

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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Wednesday, January 26, 2011

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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Monday, January 24, 2011

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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Wednesday, January 19, 2011

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:  

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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Monday, January 17, 2011

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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Wednesday, January 12, 2011

Watch Out For CEP Problems in 2011

Asia map pastel deImage 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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Tuesday, January 11, 2011

FDA Dietary Supplement Guidance for Small Businesses

Food and Drug Administration logoImage via Wikipedia
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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Monday, January 10, 2011

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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Wednesday, January 5, 2011

Parents - Are Your Kids Using Drugs?

A categorization of hard (red), soft (yellow) ...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:


Partnership for Drug-Free Kids - Where families find answers


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




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