Saturday, February 21, 2015

The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech | RAPS

Explore the entire list of links: The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech | RAPS:

"Regulatory Focus has assembled this list of the most important FDA webpages, government websites and non-governmental websites, all in the hopes of making FDA-related information easier to find.

This page is intended to assist anyone interested in FDA, including regulatory professionals, journalists, academics, patients, healthcare providers and stock traders."

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Thursday, February 19, 2015

Candidate to Lead FDA Has Close Ties to Big Pharma | TIME

Read more about Robert Califf: Candidate to Lead FDA Has Close Ties to Big Pharma | TIME:

"The agency faces potentially dramatic changes this year as Congress prepares to rewrite many of the rules for how drugs and medical devices are reviewed and tested for safety and efficacy. Califf is widely respected in the public and private sectors, but his candidacy is seen by some as a threat to the independence and authority of the FDA, thanks to his views on the need to accelerate change and his deep financial and intellectual ties to the pharmaceutical and medical device industries."

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Tuesday, February 17, 2015

GMP Olympics Annual Update - cGMP Training

So your team thinks they “know it all” about CGMPs? This course puts them to the test!

This cGMP Olympics course tests their knowledge of the regulations during one day of these highly interactive activities:
  • Heard On the Street 
  • CGMP Speed Dash 
  • CGMP Challenge 
  • Inspection Detection 
Everyone learns something new in class!

Call Allan Dewes (415-948-5220) to see how this course addresses your site’s specific training needs.
Learn more: Olympics for Pharmaceutical & Biotech Manufacturers - GMP Training by SkillsPlus Intl Inc.

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Friday, February 6, 2015

The Head of the FDA is Leaving. Here’s Why That’s a Big Deal. | TIME

Read the full article: The Head of the FDA is Leaving. Here’s Why That’s a Big Deal. | TIME:

"The role of the FDA Commissioner will be central in deciding when and whether to defend the agency’s powers in the face of deregulatory reforms, not least because both parties and the White House support varying degrees of change. “The administration is very engaged,” in the changes afoot on Capitol Hill, says one Democratic Senate aide, and “Any incoming FDA commissioner is going to play a big role in the process.”"

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Thursday, February 5, 2015

CGMP Training - GMP Essentials for Drug Manufacturers

GMP Essentials for Drug Manufacturers - An Onsite GMP Training Course

Intended for

  • new employees and non-cGMP transfers who need basic cGMP training, or
  • current staff or those individuals needing refresher training.

This highly interactive course gets everybody talking about current CGMP practices, underlying laws and regulations, the consequences of non-compliance, and recent trends. Many CGMP principles are experienced hands-on in this session. This course is usually customized to meet the needs of the organization, and can be designed to run over 1-3 days. Call Allan Dewes, (415) 948-5220, to discuss your specific needs. 

Read feedback from some of our past students (what they say about this course):

  • The exercises were great! 
  • The lack of excessive breaks was a great time saver.
  • Lively and friendly
  • The instructor's experience was very helpful. 
  • Group activities helped in the learning. 
  • It never dragged on. 
  • Allan seems to know when to move on. 
  • Teacher was great! 
  • Content explained clearly 
  • A nice balance of PowerPoint and activities 
  • This class helped me see where we need to make changes in what we are doing. 

Learn more about this onsite cGMP training course, GMP Essentials for Drug Manufacturers - GMP training by SkillsPlus Intl Inc. 

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Pfizer to Buy Hospira for $16 Billion - WSJ

Read the full article:  Pfizer to Buy Hospira for $16 Billion - WSJ:

"Pfizer Inc. agreed to buy Hospira Inc., a maker of injectable drugs and infusion technologies, for about $16 billion, putting its cash to work as it deals with billions lost in sales from drugs losing patent protection.

Hospira shareholders will receive $90 a share in cash, a 39% premium to Wednesday’s close. Shares surged 37% to $88.50 premarket. The stock’s previous high, set earlier this year, was $66.56 a share."

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Tuesday, February 3, 2015

Obama: Let's Take Food Regulation out of FDA | RAPS

Read the full article: Obama: Let's Take Food Regulation out of FDA | RAPS:

"The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget.

"This new agency would be independent from FDA and have primary responsibility for food safety inspections, enforcement, applied research, and outbreak response and mitigation," the White House explains in the budget. "The new agency would be charged with pursuing a modern, science-based food safety regulatory regime drawing on best practices of both agencies, with strong enforcement and recall mechanisms, expertise in risk assessment, and enforcement and research efforts across all food types based on scientifically supportable assessments of threats to public health. The agency would also serve as the central point for coordinating with State and local entities and food safety stakeholders.""

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