Saturday, February 27, 2010

Warning - Protect Your Children From Choking On Killer Hot Dogs

A cooked hot dog garnished with mustard.Image via Wikipedia
It sounds funny. Unfortunately, this is serious business.  Read this US New and World Report news article, Kids and Killer Hot Dogs? 3 Tips to Prevent Choking on Food.

In a nutshell, here are three practical ways to reduce choking risk for children:

  1. Re-engineer children's food yourself to reduce choking hazards. 
  2. Cook foods intended for small children until soft.
  3. Keep high-risk foods like peanuts, peanut butter, marshmallows, chewing gum, meat sticks, and round candy away from children.
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Wednesday, February 24, 2010

Another Free GXP Checklist!

Checkout this free checklist made available by the Auditing Group, Inc., Audit Checklist for Drug Industry.

It's another resource and perspective on approaching FDA GMP audit preparedness.

Additional Resources:
ISO 13485:2003 and FDA QSR (21 CFR 820) Internal Audit and Gap Analysis Checklist

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Monday, February 22, 2010

Brand New! FDA 2013 Orange Book 33rd Edition (pdf)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

New! - The 2010 FDA Approved Drug Products with Therapeutic Equivalence Evaluations 30th Edition (also known as the Orange Book).

Complete! - This FDA Orange Book 30th Edition is current through December 31, 2009.

Learn more about the Orange Book on the FDA website - Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act).

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Sunday, February 21, 2010

FDA Webinar on Access to Investigational Drugs - Feb 23, 3p ET

The FDA is hosting a webinar where you can learn more about access to investigational drugs. The featured speakers, Theresa Toigo, Director, Office of Special Health Issues and Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues, will discuss what to consider when deciding whether to seek access to an investigational drug and the ways to access investigational drugs. There will be time for questions following the presentation. The 30 minute webinar will be held Tuesday, February 23, at 3 p.m. ET.

You can find out more information about the webinar, including how to participate in the webinar, on the Upcoming Webinar on Access to Investigational Drugs web page.

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Saturday, February 20, 2010

Univ of CA CMCR - Evidence Cannabis Is A Promising Treatment

Illustration of the pain pathway in René Desca...Image via Wikipedia
The Center for Medicinal Cannabis Research: Report to the California Legislature (2010) - pdf reports:
"The CMCR has successfully conducted the first clinical trials of smoked cannabis in the United States in more than 20 years. As a result of this program of systematic research, we now have reasonable evidence that cannabis is a promising treatment in selected pain syndromes caused by injury or diseases of the nervous system, and possibly for painful muscle spasticity due to multiple sclerosis."
Learn More:
Understanding Marijuana: A New Look at the Scientific Evidence

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Wednesday, February 17, 2010

FDA - 8 Free Tips For Effective 483 Responses

OK, now that you've gotten that darn 483, now what?!

Here are 8 free tips on how to effectively respond to a 483 (pdf) , and these tips come from the FDA.

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Saturday, February 13, 2010

Dietary Supplement Fact Sheets by NIH Office of Dietary Supplements

Nice source of information about dietary supplements, National Institutes of Health Office of Dietary Supplements Fact Sheets.

According to the NIH ODS:

The Office of Dietary Supplements, a part of the National Institutes of Health, works to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public about the efficacy and safety of dietary supplements in order to foster an enhanced quality of life and health for the U.S. population.
Learn more:
Guide to Popular Natural Products

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Monday, February 8, 2010

FDA - PREDICT - Imported Food and Drug Safety Tool - Video

The FDA announced the launch of a new risk-assessment tool to ensure the safety of imported food and drugs. The web-based PREDICT system will rank the risk hazards of food and drugs as they enter the country and allow inspectors to focus on the most likely threats to public health.

PREDICT uses a scoring system that determines the risk level of the imported products. Under the new system, shipments would be flagged for additional screening on a score that is based on their country of origin, manufacturers' safety records and their contents. The program is scheduled to first be implemented in New York.

FDA web page on PREDICT (also links to the video, just in case the embedded video breaks)



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Saturday, February 6, 2010

McCain Bill Could Deny Access To Dietary Supplements

John McCain official photo portrait.Image via Wikipedia
This is starting to get interesting. This Online PR News article, Senator McCain Files New Bill That Attacks Your Access to Supplements Bill Would Repeal Key Sections of the Dietary Supplement Health and Education Act says:
Senator McCain has filed a new bill that attacks your access to supplements and would repeal key sections of the Dietary Supplement Health and Education Act.
According to the Alliance for Natural Health USA, the bill is named The Dietary Supplement Safety Act (DSSA). DSSA would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA) and significantly diminish access to a broad range of dietary supplements. If passed it's likely that the FDA will have greater authority and oversight over dietary supplements.

Previous Posts:
Make Dietary Supplements GMP Compliant

Further Reading:
FDA Website on Dietary Supplements
PDR for Nonprescription Drugs, Dietary Supplements, and Herbs 2010 (Physicians' Desk Reference (Pdr) for Nonprescription Drugs and Dietary Supplements)

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Monday, February 1, 2010

Make Dietary Supplements GMP Compliant

Mark Wolf writes a succinct 10 tip GMP primer for dietary supplement manufacturers, How GMPs Ensure a Quality Capsule.

In a nutshell, you need to pay attention to:

  1. Standard operating procedures (SOPs)
  2. Raw materials testing
  3. Validation
  4. Cleaning procedures
  5. Equipment maintenance
  6. Environmental controls
  7. Product testing
  8. Packaging and labeling requirements
  9. Documentation for traceability
  10. Training
Related Reading:
The Pill Book Guide to Natural Medicines: Vitamins, Minerals, Nutritional Supplements, Herbs, and Other Natural Products

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