Wednesday, December 30, 2009

FDA Most Common Drug and Device 483 Items

The AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 items.

You'll want to read them all, and here are teasers from each category:

Drug GMP FDA-483 (observational) items:

  • Responsibilities and procedures of the Quality Control unit are not in writing
The most common Medical Device GMP FDA-483 (observational) items:
  • Deficiencies in complaint file system
Previous Posts:
FDA Says You Only Have 15 Days To Respond To Form 483
10 Tips - How to Avoid FDA 483 and Warning Letters
CAPA Problems - Most often cited 483 deficiency
FDA Says - Unwise To Ignore Form 483
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

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Monday, December 28, 2009

Pharma Mergers - 2009 review - 2010 predictions

Continuing the thread of the pharma year in review, and what 2010 might look like.

Here's a Motley Fool look at 2009 and 2010 from the perspective of pharmaceutical mergers and acquisitions, 2009: The Year Pharma Learned to Love Itself.

In a nutshell:

  1. 2009 ushered in a number of consolidations
  2. Consolidations might not work well or scale well due to the challenges of integration
  3. The author, Brian Orelli predicts for 2010, "While anything is possible, I wouldn't expect much more consolidation of major drugmakers."

Previous Posts:
Cramer - Top 4 Healthcare Predictions for 2010
Biotechnology Trends 2010 - Free Report
Looking Ahead to Pharma 2010 - Through the IBM innovation lens
GMP Training - The end is near - I mean 2009!
IMS Predicts Pharma Growth in 2010

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Saturday, December 26, 2009

FDA Holiday Food Safety

The holidays are about spending time with friends and family. Naturally, food will be served and shared. So beware! Take a few moments to review best food handling practices to keep everybody happy and food healthy!

Follow these FDA food safety recommendations, Food Safety Tips for Healthy Holidays, or download this newsletter, Food Safety Tips for Healthy Holidays (pdf).

Bottomline...

  1. Clean
  2. Separate
  3. Cook
  4. Chill

Previous Posts:
Happy Thanksgiving - Celebrate These Food Safety Tips

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Wednesday, December 23, 2009

Cramer - Top 4 Healthcare Predictions for 2010

Economic Map of the World: Emerging Markets an...Image via Wikipedia

... rather, that's Cliff Cramer.

In looking for 2010 trends, and predictions, I stumbled across his predictions, Top 4 Healthcare Predictions for 2010. It's the start of an interesting and provocative discussion of his 4 predictions (which I've truncated):
  1. Multi-national pharmaceutical and medical technology companies will increase their investments in emerging markets.
  2. Information technology will make greater strides in a healthcare industry.
  3. Healthcare reform will continue across developed and developing markets.
  4. Consolidation will be a major theme in 2010.

I recommend you go to his post, and jump into the discussion. On some gut level, I'm hoping the predictions ring true as my retirement investments will benefit.

Previous Posts:
Biotechnology Trends 2010 - Free Report

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Monday, December 21, 2009

FDA Cosmetics GMP Inspection Checklist - Free

The FDA offers a Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetic establishment instructions, that are excerpted from the FDA's Inspection Operations Manual. The FDA checklist may serve as guidelines for effective self-inspection. According to the FDA, a good inspection score means that an establishment follows good manufacturing practice.

Previous Posts:
30 FDA GMP Compliance Tips
FDA Audit Preparation - Audit Theory - Be Ready

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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Saturday, December 19, 2009

FDA Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling.

Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval. Here's what you can find:

FDA's Concerns About Unapproved Drugs
Background Information
Unapproved Drugs Initiative
Compliance Policy Guide
Enforcement Actions
Important Documents
Publications
Industry Information
Unapproved Drug Decision Tree
Unapproved Drugs Coordinator
Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator
Marketed Unapproved Drugs Workshop
Required reporting of adverse events

Health Care Professional Information
Determining if a drug is FDA approved
Orange Book
NDC Directory
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda
Legal mechanisms to access unapproved drugs
Reporting of adverse events
Consumer Information

But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF).

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Wednesday, December 16, 2009

Biotechnology Trends 2010 - Free Report

English: Public domain image from cancer.gov h...Image via Wikipedia

Here's the next installment of my hunt for 2010 trends, forecasts, and predictions.

Pharma-Reports.com just announced the availability of its executive report, Biotechnology Trends 2010 (free). I've provided the link to the request form. The report examines the most significant trends in biotechnology and their impact on rising health care costs, the aging population, and an overall rise in the incidence of disease. The report also discusses scientific advancements in proteomics and biomarkers, molecular manufacturing, and the development of smart materials.

Previous Posts:
Looking Ahead to Pharma 2010 - Through the IBM innovation lens
GMP Training - The end is near - I mean 2009!
IMS Predicts Pharma Growth in 2010
CDC - Brand New 2010 Yellow Book for Travelers - free - online

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Monday, December 14, 2009

FDA New Guidance on PET Drugs GMPs

This FDA guidance, Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP), is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.

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Saturday, December 12, 2009

Say No To Drugs PSAs - Public Svc Announcements over the yrs

Updated April 21, 2017
This post didn't age well. The video links have broken, so I've removed them from the original post. You can get a sense of the video with this collection of photos:
PSAs Say No to Drugs

- -  most of the original post follows below  - -

I was catching up with news this wet Saturday morning and ran across this CBS News mini-history of anti-drug messaging over the years. Enjoy!

For related photos and links specific to this video clip go to CBS News PSAs Say No to Drugs Photos.

Previous Posts:
Sugar As Addictive As Cocaine Or Heroin
Epidemic Teen Addiction To Prescription Drugs (video)
Parents, Get A Clue About Teen Drug and Alcohol Abuse
Are Your Teens Abusing Drugs? - 4 Tips

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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
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Free GMP Training Tips

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Monday, December 7, 2009

FDA - Food Defense Tool - CARVER + Shock

The FDA of the U.S. Department of Health and Human Services and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) have created an online tool to help farmers and producers assess and mitigate vulnerabilities in their production processes.

The risk assessment tool (free software) called Agriculture CARVER + Shock is designed to help the food industry at the farm level – implement food production security methods. CARVER + Shock is an offensive targeting prioritization tool adapted from the military version (CARVER) for use in the food industry. The tool can be used to assess the vulnerabilities within a system or infrastructure to an attack. It allows the user to think like an attacker to identify the most attractive targets for an attack. By conducting a CARVER + Shock assessment of a food production facility or process, the user can determine the most vulnerable points in their infrastructure, and focus resources on protecting the most susceptible points in their system.

What is CARVER + Shock?What are People Saying About CARVER + Shock?
What Does C-A-R-V-E-R + Shock Mean?
How Do Federal Agencies Apply CARVER + Shock as a Food Defense Tool?
Why CARVER Software?
What Does CARVER Software Do?
System Requirements
Download Manufacturing Software
Download Agriculture Software

Previous Posts:
Upton Sinclair Belated Birthday - Inspired FDA Creation
FDA Updates Warning Letters Web Page

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Saturday, December 5, 2009

HIV AIDS - 97 US Medicines in Testing

The Red ribbon is a symbol for solidarity with...Image via Wikipedia

This is a really nice snapshot of some of the clinical testing going on in the HIV AIDS field, PhRMA's Pharmaceutical Researchers Are Testing 97 Medicines And Vaccines for HIV and Related Conditions (pdf).

The article provides a quick overview for medicines grouped by:
  1. Anticancer
  2. Antiviral
  3. Gene therapy
  4. Immunomodulators
  5. Vaccines
  6. Other

Previous Posts:
Abzymes Pinpoint The HIV Achilles Heel
109 HIV Drugs And Vaccines Under Development
Listen To People With AIDS and HIV (audio)

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Saturday, November 28, 2009

Bah Humbug - Oh, that should be Bed Bug!

I just read a newspaper article reporting that users of http://www.bedbugregistry.com/ have been reporting the most complaints in Toronto and Vancouver.

I checked out the "registry" and find it both fun and enlightening. Check it out!

Previous Posts:
EPA Attacks Nasty Bed Bugs!
College Students - eccch, dorm room bedbugs! (video)

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Wednesday, November 25, 2009

Looking Ahead to Pharma 2010 - Through the IBM innovation lens

IBM Global ServicesImage via Wikipedia

2010 is approaching fast. This is the time of year I start watching out for crystal ball predictions of what's in store for us.

For example, check out IBM's vision for 2010, Pharma 2010: The Threshold of Innovation (pdf).

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Monday, November 23, 2009

GMP Training - The end is near - I mean 2009!

Yep, the year is coming to a close.

If 2009 snuck up on you and you still have some training needs, it's not too late. Arranging some onsite training might be challenging, but it's not too late to identify vendors that offer products and services that you can leverage. For example, buy some modules or materials, so that you can deliver training yourself. Or, locate vendors that offer online delivery of training via CBT (computer based training), so that you don't have to spend an arm and a leg to bring in a trainer on-site.

The fastest way to find vendors who can help you, is to use www.google.com and search on "gmp training".

2009 is almost gone, and it's time to start planning your 2010 regulatory training plan.

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Saturday, November 21, 2009

Happy Thanksgiving - Celebrate These Food Safety Tips

The scolex of Tenia soliumImage via Wikipedia

I love gathering with family at this time of year. Let's just be sure we do it with food safety in mind. Here's a collection of previous posts you might be interested in:

Time To Talk About Turkey Cooking and Food Safety

Thanksgiving Alert - Cooked Turkey Can Still Cause Food Poisoning!

Wine Lovers Dishwasher Magnet
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Wednesday, November 18, 2009

More Good News - Fighting Drug Counterfeiting - PQM

Learn about the latest worldwide effort to fight substandard and counterfeit drugs, in this PharmTech Talk article, USP and USAID Launch New Program to Improve Drug Quality.

In a nutshell, Alexis Pellek writes:

"The $35-million program, called Promoting the Quality of Medicines (PQM) will work to improve the safety of medicines in approximately 30 countries worldwide by working to strengthen regulatory bodies, increasing the supply of legitimate products, detecting and reducing availability of counterfeits through testing and other methods, and raising public awareness of the dangers of substandard drugs."
Previous Posts:
FDA Draft Guidance on Anti-Counterfeiting
FDA On Drug Counterfeiting
FDA - Global Drug Supply Chain Needs Better Oversight

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Trackback url:
http://blog.pharmtech.com/2009/11/06/usp-and-usaid-launch-new-program-to-improve-drug-quality/trackback/

Monday, November 16, 2009

FDA CFR Title 21 Database Search Page - Excellent!

Initially, I wasn't too thrilled about the FDA website getting re-designed. Now I'm starting to like what I'm seeing. For example, I'm seeing more user friendly pages like the CFR Search page.

If you don't have the Search CFR Title 21 Database page bookmarked, you really should.

It's a terrific database search tool for finding CFR contents by:

  • Section number
  • Part number
  • Full text search

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Wednesday, November 11, 2009

Global Supply Chain - Counterfeiting - Sobering

This Q & A article from PharmTech is an interesting read, Preventing counterfeits from entering the supply chain.

I find it sobering that a small percentage of drugs are counterfeit, yet counterfeited drugs represent a growing and substantive volume of tampered, contaminated, diluted, substituted, adulterated, and misrepresented ingredients.

Previous Posts:
Rx-360 - A non-profit to help secure the supply chain (podcast)
FDA On Drug Counterfeiting

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Saturday, November 7, 2009

AMA Unveils Flu Assessment Tool

Structure of the influenza virion. The hemaggl...Image via Wikipedia

The American Medical Association (AMA) launched AMAfluhelp.org, a comprehensive Web-based patient flu health-assessment program. It walks patients through a series of questions to determine the severity of their flu symptoms based upon the latest Centers for Disease Control (CDC) and Prevention guidelines.

With the influenza state of emergency with us, you can never have too many of these useful gadgets and widgets around.

Previous Posts:
FDA Search Widget of Fraudulent H1N1 Products
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added

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Friday, November 6, 2009

FDA FAQ On IV Peramivir To Treat H1N1 Flu

Recently, the FDA Says Yes to IV Peramivir To Treat Flu.

Now here's the FDA followup with Peramivir IV Questions and Answers for Health Care Providers.

It's a pretty comprehensive collection of over 20 questions and answers, and concludes with a set of related links.

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Wednesday, November 4, 2009

FDA Medical Device Online Courses In Chinese - Free

Here's more from the FDA's CDRH Learn treasure trove of free online courses. ... and these are in Mandarin Chinese!

As of this posting, there's only one FDA CDRH Learn course in Mandarin, but you can expect more courses to be on their way. Here's what's available so far:

Quality System Regulation 21 CFR Part 820 Basic Introduction
Online Video Presentation
Transcript

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Monday, November 2, 2009

FDA Medical Device Online Courses - Free

This is a great example of your government dollars working for you.

The FDA offers several free CDRH Learn online courses. These courses are intended for industry on safety and effectiveness of medical devices and exposure to radiation from medical devices.

Here's what's neat about the courses. Each course includes a captioned video, slide set, and post-test.



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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!















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Saturday, October 31, 2009

FDA And Others To Study Lasik Problems

A subconjunctival hemorrhage is a common and r...Image via Wikipedia

After having a conversation about Lasik complications with a co-worker, I thought I'd share this article with you, from the LA Times, Three federal agencies to assess potential Lasik problems.

As much as I'd like to get Lasik corrected vision, I'm very reticent to do so. My co-worker has looked into this matter for herself, and she tells me that the 2% complication rate is the best possible scenario. This low rate in part is due to: the usage of the best equipment, and the procedure being performed at the hands of a well-trained practitioner who's completed many thousands of procedures.

As for me, even a 2% complication rate is too much risk for me. How about you?

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Friday, October 30, 2009

FDA Says Yes to IV Peramivir To Treat Flu

The FDA announced today that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:

  • the patient is not responding to either oral or inhaled antiviral therapy, or

  • when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;

  • for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
I've been following this drug for sometime now, and I'm glad to see that it's found a niche during this flu pandemic.

Additional Related Information From The FDA:
EUA Letter of Authorization
EUA Fact Sheet for Health Care Providers
EUA Fact Sheet for Patients and Parents/Caregivers
Information for Healthcare Professionals Sheet (HCP) on mandatory adverse event reporting for emergency use of peramivir under EUA

Previous Posts:
FDA Search Widget of Fraudulent H1N1 Products
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added

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