Tuesday, August 30, 2011

Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com

Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com ('via Blog this')

A good read on the shaky tension between legitimate, tainted, and dangerous supplements. The supplement industry blames the FDA for failing to institute mandatory recalls and seize tainted goods.

In a nutshell:

Daniel Fabricant of the FDA says, "the growing availability of tainted products represents a serious public health problem, one that could taint the dietary supplement industry as a whole."
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Friday, August 26, 2011

FDA Hurricane Preparedness Checklist

Updated March 25, 2021

Hurricane season is coming soon, so be prepared.

According to the FDA, "The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages."


The FDA breaks down preparations into these categories:


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Wednesday, August 24, 2011

GMP Proper Documentation Tips - Free

Updated 10/19/2015:
The post below is outdated.  You might be interested in cGMP training by SkillsPlus Intl Inc.

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I found this helpful document, it's free, Documentation - Rules for Completion (GMP Trainers' Survival Kit II) - PDF

It could be especially useful for classroom trainers, or for staff trying to reinforce GMP good documentation practices.

Return Home: http://drughealth.blogspot.com/

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Tuesday, August 23, 2011

Online Pharmacy Dangers Lurk

Beware, if you search for pharmacies online, there's a good chance you'll encounter infected websites, and rogue and illegal pharmacies: http://consumer.healthday.com/Article.asp?AID=655839

Monday, August 22, 2011

IATA Perishable Cargo Regulations

The International Air Transport Association (IATA) represents some 230 airlines comprising 93% of scheduled international air traffic.

IATA publishes The Perishable Cargo Regulations Manual: THE standard for cargo handling (buy online)

According to IATA, The Perishable Cargo Regulations (PCR) manual is the leader in temperature control and cold chain management for goods from the health care and food sectors, including pharmaceutical products and non-hazardous biological materials and includes everything you need to properly prepare, package and handle time and temperature sensitive goods quickly and efficiently.

Additional IATA resources related to perishable cargo

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Saturday, August 20, 2011

GMP Library Search Tool - Free

Updated July 29, 2021

The library is no longer available.

You might also be interested in:
Free GMP Tools by PharmOut

---  the original post follows below  ---

PharmOut, a professional consultancy specializing in GMP compliance, has created an online database of GMP guidelines.

This database is free to access and allows the user to search across all English language GMP guidelines, past and present:
GMP Library Search by PharmOut

Friday, August 19, 2011

The Pfizer Inside Story - WOW

The latest issue of Fortune magazine (Aug 15, 2011) found its way into my hands this morning.

The title screamed loudly to me, Inside Pfizer's palace coup (full text Fortune magazine story online) - Did CEO Jeff Kindler get pushed out because he was shaking up the dysfunctional pharmaceutical giant - - - or because he was an ineffective leader?

I can't describe this compelling story any better than the Fortune magazine cover:

What happened at Pfizer. The inside story of revenge, betrayal, and power at the top of the world's largest drug company.
The tale is a gripping must read. Kudos to the authors:  Peter Elkind and Jennifer Reingold (with Doris Burke)

Monday, August 15, 2011

Medical Device Premarket Review - FDA Draft Guidance


For the first time, the U.S. FDA (Food and Drug Administration) has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily.

In its review of PMAs, the FDA uses safety data and effectiveness data. The safety data addresses risk, and the manufacturer’s ability to mitigate that risk. The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.

Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.

Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.

The guidance also proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA’s decision making process even more transparent.

Learn more:
FDA - Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

Monday, August 1, 2011

Colon Cleansing Risky - Controversy

Updated Sept 8, 2016

You might also be interested in:
You Asked: Is Getting a Colonic Dangerous? - TIME

- -  original post follows below  - -

I've never had a colon cleanse, though I know friends who swear by them.

I'm inclined to avoid them, after reading about the latest findings reported by Mishori (reported in the Journal of Family Practice).

For a quick read, go to WebMD and read, Colon Cleansing May Be Risky, Study Finds - Hazards May Include Nausea, Vomiting, Kidney Failure; Advocates Cite Energy Boost, Other Health Benefits.

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