Bad Pharma - Book Review

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No doubt this will be a provocative read.  Follow the link to a comprehensive review of the book.

Science-Based Medicine » Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry:

"Closing thoughts
This is a book with important messages for patients, health care professionals, governments, and the pharmaceutical industry. It may anger, and even infuriate you. It should. Yet Goldacre sketches out a path for reform – one in which transparency is the rule, not the exception, and one in which the pharmaceutical industry can engage with the health care system in ways that will help it do what we all want it to do – bring innovative new medications to market that improve the health and welfare of patients. This change, however, will only come when we demand better – better from pharmaceutical companies, better from regulators, and better from our fellow health professionals. Ultimately, we’ll have the industry we deserve – if we’re not willing to demand better, we’re never going to see any improvements. This book is your call to action."

'via Blog this'

Order the book through Amazon.com:
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Kindle Edition)

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FDA Awards Two New Regulatory Research Centers

Image via WikipediaFDA launches two centers to improve approval of drugs, devices - The Hill's Healthwatch:  'via Blog this'

"The Food and Drug Administration (FDA) on Wednesday awarded $2 million to support the creation of research centers tasked with improving the way new medicines and medical devices are reviewed and evaluated."

The centers will be established at the University of Maryland and Georgetown University.

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Medical Device Premarket Review - FDA Draft Guidance

For the first time, the U.S. FDA (Food and Drug Administration) has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.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

FDA Should Revamp 510(k) Medical Device Clearance Process

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Updated November 4, 2022

Some of the links broke.

You can still read about the same topic here:

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years - NAP.edu

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The LA Times reports, FDA is urged to revamp its review process for medical devices.

In a nutshell, the Institute of Medicine (IOM), an arm of the National Academy of Sciences (NAS), recommended that the system be abolished and new procedures established, IOM - Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.

Webcast of the Institute of Medicine - Public Health Effectiveness of the FDA 510(k) Clearance Process - Public Briefing (July 29, 2011)

Entertaining Healthcare Reform Animated Video Primer

This is really great stuff.  I have no patience to digest pages and pages of healthcare reform legislation.  This fun and informative animation makes it all very entertaining and digestible.



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Pharma Mergers - 2009 review - 2010 predictions

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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."

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Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)

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The FDA and medical device industry just got a wake-up call. Seems like this GAO report suggests greater rigor is needed in the premarket review process, MEDICAL DEVICES - FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. In any event, seems like this industry sector can expect potentially more rigorous regulation in the future . . . Bottomline, the reports states, "We are recommending that the Secretary of Health and Human Services direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process." From your perspective, would more stringent regulation be a good thing? 

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Nice Review of US FDA Medical Device Regulation

This is an excellent introduction to, and review of the FDA's Medical Device Regulations. This report, "Review of U.S. Medical Device Regulation," published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA). The report tackles the subject in the following sub-topics . . .

1. Introduction
2. Regulatory Definition of Medical Devices
3. Risk-Based Device Classification
4. Safety and Effectiveness Requirements
5. Food and Drug Administration Programs/Regulatory Pathways
6. Quality Systems Regulation (QSR)
7. Regulation of Drug-Device Combinations (Combination Products)
8. Guidance Documents Available to the Device Industry
9. Conclusions

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FDA Scandal Brewing - Corrupted Scientific Reviews

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Updated April 27, 2021

The original link broke.

You can still read about this topic in this article:

"Ordered, Intimidated And Coerced"? CDRH Targeted In Misconduct Probe - NWC

---  original post follows below  ---

"Top managers with the U.S. Food and Drug Administration "corrupted and interfered with'' scientific reviews of medical devices, reports this Bloomberg News article, "Democrats Probe 'Corrupted' FDA Reviews of Devices." Wow! What a powderkeg! You have to read this article, because it includes the following words and phrases, yikes!

1. Corrupted
2. Interfered with
3. Reprisals
4. Threatened
5. Accept data that isn't scientifically valid
6. Avoid and evade any accountability
7. Corruption, illegality, gross mismanagement and retaliation
8. Felt pressured to alter their work for non-scientific reasons and provide misleading information

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Health 2.0 Conference Recap (free podcast)

I wasn't able to get to the recent Health 2.0 Conference. If you missed it too, don't feel left out. This podcast provides some quick highlights on the latest Health 2.0 applications and consumer trends from the Health 2.0 Conference in San Francisco. In this Manhattan Research eHealth Trends podcast episode, Meredith Abreu Ressi tells us what we need to know, "Health 2.0 Conference Recap - Episode 23."

Related Stories:
Over 60 Million US Adults Use Health Blogs, Online Support Groups, Prescription Rating Sites, And Other Health-related Social Media Applications
Health 2.0 Conference Recap - Episode 23 (transcript)

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Health, Drug, GMP Books On The Kindle Reading Device

This could be the next iPod! I just read about the surge of Kindle (a reading device) sales in this Reuters article, "Citigroup sees better Amazon Kindle sales." Don't have a Kindle yet? Then buy a: Kindle: Amazon's New Wireless Reading Device. If you're not familar with the Kindle, then read this blog post review of the Kindle: All the Best Bits: Kindle Review.

Keeping in the spirit of this blog, here are some Kindle book titles available from Amazon.com:

1. You: Staying Young: The Owner's Manual for Extending Your Warranty
2. Smart Medicine: How to Buy the Prescription Drugs You Need at a Price You Can Afford
3. Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

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