Showing posts with label 2010. Show all posts
Showing posts with label 2010. Show all posts

Wednesday, November 23, 2011

Electronic Orange Book Online - It'll be a wait for the 2012 version

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 - - -

Electronic Orange Book Online | The Health, Drug, Prescription, and GMP Supersite:  'via Blog this'

OK you eager beavers out there!   If history serves us, you'll have to wait until the end of Q1 2012 to see a brand new cumulative version of the Orange Book that is current through the end of 2011.

In the meantime, just navigate to the link provided above for your needs.

Happy hunting, and be patient!

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Monday, November 1, 2010

Staying Alive - New AHA 2010 CPR Technique (video)

This is a major change.  Watch this video to learn about the American Heart Association (AHA) 2010 Guidelines for CPR.  The guidelines mention the song Stayin' Alive for the compression rate of 100 beats per minute. 



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Monday, August 23, 2010

Drug Safety and Accountability Act of 2010

Official photo of Senator Michael Bennet (D-CO).Image via Wikipedia
Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Bennet's press release, Senate Introduces New Bill on Drug-Manufacturing Quality Standards, says:
The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.
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Monday, February 22, 2010

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

Updated March 3, 2020:

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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Wednesday, January 27, 2010

FDA CDRH Announces Strategic Initiatives

Updated Dec 7, 2015:
The link in the original post went stale. You might be interested in:
FDA CDRH Strategic Priorities and Updates

- - - -  original post follows below - - - -

There's a lot here. I recommend you view this or download the FDA PDF, CDRH FY 2010 Strategic Priorities.

Here's what you'll find:

Executive Summary
Priority 1. Fully Implement a Total Product Life Cycle Approach
Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
Strategy 1.2. Improve Guidance and Regulation Development
Strategy 1.3. Develop a Cross-Center Compliance Strategy
Priority 2. Enhance Communication and Transparency
Strategy 2.1. Develop a Strategic Approach to Public Communication
Strategy 2.2. Improve Internal Communications
Strategy 2.3. Increase Transparency in Decision Making
Priority 3. Strengthen Our Workforce and Workplace
Strategy 3.1. Recruit, Develop, and Retain High-Quality Employees
Strategy 3.2. Leverage External Expertise
Strategy 3.3. Establish Pathways for Resolving Differences of Opinion
Strategy 3.4. Improve Internal Administrative Processes
Strategy 3.5. Make CDRH's White Oak Facilities More Workplace-Friendly
Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
Strategy 4.1. Foster Development of Medical Devices to Respond to Unmet Public Health Needs
Strategy 4.2. Develop a Personalized Medicine Program

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Monday, January 11, 2010

More Pharma 2010 Trends

... and even more pharma trend predictions for 2010.

Tracy Staton reports in What's the outsourcing outlook for 2010?, what we can expect in 2010 from an outsourcing perspective.

In summmary, expect:

  • Outsourcing won't let up in 2010
  • Outsourcing to heat-up in sales, IT, and CROs 
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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."

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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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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.


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)

Monday, October 26, 2009

IMS Predicts Pharma Growth in 2010

I can hardly believe 2009 is almost over. It's time to start looking ahead to 2010 trends. I caught this article on Pharmaceutical-ManufacturingNews.com, IMS Forecasts Global Pharmaceutical Market Growth Of 4 - 6% In 2010. IMS Health forecasts 4-6% growth in 2010, and 4-7% through 2013. 

Friday, August 14, 2009

CDC - Yellow Book for Travelers - free - online

Updated October 29, 2022

The original link broke.

Here's the latest version of the CDC Yellow Book.


---  the original post follows below  ---

When you read this, I'll be travelling. For those of you with international travel plans, you might want to check out this free online resource, the 2010 CDC Traveler's Health Yellow Book. Although this is written with the health professional in mind, anybody who's travelling can benefit from this wonderful free resource. Check it out! 

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