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.”"

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Pfizer to Buy Hospira for $16 Billion - WSJ

• People also search for FDA CGMP Online Training - recommended FDA GMP online training courses sold by SkillsPlus International Inc.

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."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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

• FDA cGMP online training courses and programs offered by SkillsPlus International Inc.

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.""

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

US FDA launches overarching Office of Pharmaceutical Quality - iPT

Updated June 28, 2025

Unfortunately, the original link is no longer available.

---  the original post follows below  ---

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."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

GMP QSR cGMP Training Course Catalog - by SkillsPlus Intl Inc.

Updated March 10, 2021 With the COVID-19 pandemic all around us, people also search for: Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses - - -  Get ready for the coming year's cGMP QSR GMP training Are you planning your CGMP training schedule for the coming year?  Do you wish you had more instructors? 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, courses, workshops, and seminars that we can bring to your plant site.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

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."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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."

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA launches openFDA to provide easy access to valuable FDA public data

• Respected FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated October 7, 2021

The original link broke.

You can still read about the same topic here:

FDA launches openFDA to provide easy access to valuable FDA public data - WorldPharmaNews

---  the original post follows below  ---

Read the full article: Press Announcements > FDA launches openFDA to provide easy access to valuable FDA public data:

"Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.

In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis."

'via Blog this'

Go to: openFDA

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Warning Letters (2012 – Q1 2014) Show FDA’s GMP Enforcement Shifting Overseas | IPQ Newsletter

• FDA cGMP online training programs by SkillsPlus International Inc.

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention | IPQ Newsletter:

"In 2012, for the first time, foreign warnings began outpacing those issued domestically. Between 2012 and the first quarter of 2014, 48 drug GMP warning letters were issued internationally compared to 44 in the U.S. [Editor's Note:  At the end of the story is a chronological listing of all 92 of the drug GMP warning letters issued between the beginning of 2012 and the first quarter of 2014, categorized into U.S. and International. The key concerns that each of the warning letters address and links to the letters themselves are provided.]"

'via Blog this'

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around