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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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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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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• Health Buzz: FDA Says Food Safety Will Require Better Funding, and Other Health News (health.usnews.com)

Cramer - Top 4 Healthcare Predictions for 2010

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... 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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• Merck buys British maker of biotech medicines (sfgate.com)
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• Drug Companies Raising Prices Ahead Of Reform (huffingtonpost.com)

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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GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

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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Biotechnology Trends 2010 - Free Report

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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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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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• Need Of Regulatory Affairs In Biotechnology (slideshare.net)

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

Watch CBS News Videos Online

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 - 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

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FDA Updates Warning Letters Web Page

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HIV AIDS - 97 US Medicines in Testing

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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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