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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Tuesday, January 13, 2015

US FDA launches overarching Office of Pharmaceutical Quality - iPT

Read the full article: US FDA launches overarching Office of Pharmaceutical Quality - iPT:

"Within the OPQ, the agency will create an Office of Surveillance, which will be tasked with creating new quality metrics, and will let OPQ inspectors know if they need to inspect manufacturing facilities during an NDA (new drug application) review.

After a new industry range of metrics is published, she added that FDA will take “the first two years to make sure we’re measuring apples and apples” and allow facilities to see where they stack up against competitors.

The agency will undergo the “same type of work but new inspection protocols will be” standardized and help industry understand how pre-approval and surveillance inspections can be done, Woodcock said."

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Friday, January 2, 2015

New! - 2015 cGMP Training Course Catalog - by SkillsPlus Intl Inc.


Get ready for 2015 cGMP training
  1. Are you planning your CGMP training schedule for 2015? 
  2. Do you wish you had more instructors?
  3. Do you need more time to develop the courses?
If you answered yes to any of the questions above, then take a look at our current list of classes that we can bring to your plant site.
Current Course Listing 
Allan Dewes
Allan Dewes - President
of SkillsPlus Intl Inc.
  1. GMP Essentials for Drug Manufacturers
  2. GMP Olympics Annual Update
  3. Qualstar: A Pharmaceutical CGMP Simulation
  4. Executive Session Annual Update: GMPs
  5. FDA Inspection Training
  6. Auditing for Compliance
  7. Root Cause Analysis for Better Deviation Investigations
  8. Writing Better Investigation Reports
  9. Advanced Root Cause Analysis Investigator Training
  10. Writing More Effective Procedures
  11. Critical Thinking Skills
  12. Creating Responsibility and Accountability
  13. Risk Assessment: Failure Mode Effects Analysis (FMEA)
  14. Overcoming Human Errors
  15. Train-the-CGMP Trainer Workshop

View our catalog:  

If you don't see what you need, just give us a call at (415) 948-5220.


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FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog

View the chart & read the full article:  FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog:

". . . FDA 483 Inspectional Observations for Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009."

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Friday, December 19, 2014

FDA Studying How it Can Use Drones to Conduct Inspections | RAPS

Read the full article: FDA Studying How it Can Use Drones to Conduct Inspections | RAPS:

"While there is currently "no formal drone program in development," the agency is currently "conducting preliminary feasibility testing on possible applications for drone technology in fulfillment of the agency's mission," Andrea Fischer, an FDA spokeswoman, told Focus.

Using drones during FDA inspections of manufacturing facilities could have far-ranging implications. Inspections could, for example, much more easily survey an entire manufacturing site, which can sometimes span several acres and include difficult-to-access sections, such as rooftops. In agricultural settings, in particular, the use of drones might allow FDA to survey an entire site much more easily."

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Saturday, November 29, 2014

Thursday, November 20, 2014

FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer

Read the full article: FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer:

"These cases show that FDA will aggressively pursue violators of the dietary supplement GMP requirements.   Because the consent decrees include a recall provision, a shut-down provision, and a requirement that FDA confirm that they are in compliance before they can reopen, the companies may well end up being put out of business permanently.

FDA does not bring a lot of injunction cases per year.  Four (or more) injunctions related to dietary supplement GMP suggests that this area is a high enforcement priority for the Agency."

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Wednesday, November 19, 2014

FDA - News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality

Read the full article: News & Events > From our perspective: Assessing, safeguarding pharmaceutical quality - FDA.gov

"Lucinda Buhse, PhD, acting director, Office of Testing and Research, Office of Pharmaceutical Science, discusses efforts underway in FDA’s laboratories to help assure high-quality drug products are available for the public."

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The article covers:
  • Assessing pharmaceutical quality
  • Measuring pharmaceutical quality across the drug lifecycle
  • FDA’s additional roles in safeguarding quality
  • Research and innovation in CDER’s drug quality testing program
  • Continuing to help protect consumers from harm
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Tuesday, November 11, 2014

FDA - Constituent Updates > New CFSAN Center Director Announced

Read the full article: Constituent Updates > New CFSAN Center Director Announced - FDA.gov:

"The U.S. Food and Drug Administration today announced a change in leadership at the Center for Food Safety and Applied Nutrition. In January 2015, Dr. Susan T. Mayne will take the reins from Michael M. Landa, who has led the Center since 2010, providing critical leadership on major food safety and nutrition initiatives.

Mayne is an internationally recognized public health leader and scientist, who is also known as an outstanding administrator and coalition builder. With rigorous training in nutrition, toxicology, and epidemiology, she understands the fundamental relationship between science and FDA’s public health mission"

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Thursday, November 6, 2014

It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS

Read the full article: It's Not Just You: FDA Regulatory Requirements Really Are Increasing | RAPS:

"According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

While regulatory professionals working with FDA needed to know just 16,329 requirements in 2000, they needed to know 18,777 in 2012, according to the data."

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Thursday, October 23, 2014

Federal Register | FDA Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

Federal Register | Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability:

"FDA is announcing the availability of a guidance for industry entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” On July 9, 2012, FDASIA (Pub. L. 112-144) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C Act to make a drug adulterated that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” As required by Section 707, FDA is issuing this guidance to define the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of Section 501(j) of the FD&C Act."

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Read the FDA Final Guidance:
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF - 106KB)

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Thursday, October 2, 2014

Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov

Read the full article: Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov:

"This Strategic Priorities document articulates the goals and priorities that guide our Agency. It creates a framework that will allow us to integrate and achieve our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

While the priorities are individually important, they are also interconnected and cannot be addressed in isolation. Thus, for example, regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities. The cross-cutting nature of this plan will help FDA achieve the greatest benefits.

This document also sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to – and making better informed decisions about – the products FDA regulates. It describes in detail key strategies to help the Agency fulfill its public health mission."

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Download the document:  FDA Strategic Priorities 2014-2018 (pdf)

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Wednesday, October 1, 2014

The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov

Read the full press release:  Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:

"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."

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