Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances

Follow the link below to a webpage that contains links to the 3 final guidances.

Read the full article: Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances - FDA.gov:

"In June 2014, FDA issued three final guidance documents reflecting FDA’s current thinking on certain issues related to the use of nanotechnology in FDA-regulated products. FDA prepared these final guidances after taking into account public comment received on the corresponding draft guidance documents previously issued in 2011 and 2012. These guidance documents are being issued as part of FDA’s ongoing implementation of recommendations from FDA’s 2007 Nanotechnology Task Force Report."

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Pure Food and Drug Act passes in Congress, June 23, 1906 - POLITICO.com

English: Theodore Roosevelt, circa 1902 (Photo credit: Wikipedia)

Read the full article: Pure Food and Drug Act passes in Congress, June 23, 1906 - Andrew Glass - POLITICO.com:

"On this day in 1906, the Pure Food and Drug Act cleared a hurdle toward its passage when the House and Senate both endorsed a joint conference committee report favoring the bill. The House vote was 240-17. President Theodore Roosevelt signed the landmark Progressive Era legislation into law on June 30.

The statute for the first time regulated food and drugs that moved in interstate commerce and forbade the manufacture, sale or transportation of poisonous patent medicines. It arose, with strong White House support, in the wake of exposés by such muckrakers as Upton Sinclair and Samuel Hopkins Adams."

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SecuringIndustry.com - USP starts field trials of FDA fake drug screening device

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Read the full article: SecuringIndustry.com - USP starts field trials of FDA fake drug screening device:

"The US Pharmacopeial Convention has started field testing a new low-cost screening device designed to detect counterfeit and poor quality medicines quickly.

The handheld CD-3+ unit - originally developed by the US Food and Drug Administration (FDA) - uses multiple light sources to look at packaging using different wavelengths and provide images that can be interpreted by the user to differentiate between genuine and falsified medicines. The approach may also be applicable to individual tablets."

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

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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."

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Go to: openFDA

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Improving Documentation of GMP Procedures - Natural Products Insider

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Follow the link below to read Richard Soltero's full article, written for dietary supplement manufacturers.

Improving Documentation of GMP Procedures - Natural Products Insider:

"Here are a few key GMP guidelines that help manufacturers avoid FDA citations and sanctions:

• Document all procedures in manufacturing operations.
• Maintain all records for plant and equipment cleaning processes.
• Mandate techniques for product sampling.
• Ensure approval by QC personnel for all procedures, tests, controls and deviations.
• Implement a control process for product labeling.
• Require QC personnel to provide results of initial or final products.
• Provide a procedure to follow if documented specifications are not met.
• Retain all written documentation for at least one year past the shelf life of the product or two years past the dissemination date of the last batch of dietary supplements."

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FDA warning letter says Sun Pharma plant hid batch failures - FiercePharma Manufacturing

Sun Pharmaceutical wants to buy long-troubled Ranbaxy Laboratories.

FDA warning letter says Sun Pharma plant hid batch failures - FiercePharma Manufacturing:

"A warning letter for a now banned Sun Pharmaceutical plant in India, posted today by the FDA, shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn't hit. In fact, FDA inspectors fished torn and partially destroyed raw data cGMP records out of the trash."

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

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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.]"

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17 Awesome Resources on Micro-Learning - eLearning Industry

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17 Awesome Resources on Micro-Learning - eLearning Industry:

"Micro learning is learning in small steps (contrary to the traditional approach of learning through hour-long courses). It is made possible with the aid of small, well planned, bite-sized chunks of units or activities (also called learning nuggets) that are short-term, digestible, and easily manageable. ...

Micro learning is going to be the future of learning. It is all set to transform how we learn both for our personal as well as our professional needs. We foresee micro learning tools evolving into an essential component of any enterprise learning toolbox. "

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Root Cause Analysis - GMP Training

FDA > Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses

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     Wholesaler Course | 3PL Course | Reverse Distributor Course

Follow the link below to see a list of the U.S. state agencies responsible for drug wholesaler licensing. The list is organized by: State, Agency Name, and Website Link or Contact Info.

Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses - FDA:

"U.S. State Agencies Responsible for Licensing Wholesale Prescription Drug Distributors" ...

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• Florida Certified Designated Representative (CDR) online exam prep course
• The Designated Representative Institute

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Related articles

• FDA - Drug Integrity and Supply Chain Security - Another counterfeit cancer medicine found in U.S. - Illegal practice puts patients at risk (drughealth.blogspot.com)
• FDA Awards Two New Regulatory Research Centers (drughealth.blogspot.com)

I Like GMPs - PharmaManufacturing.com

I Like GMPs: Even if regulators didn’t require GMPs, I would follow the practices - PharmaManufacturing.com:

"Yes, regulators have set clear expectations for those of us in pharmaceutical manufacturing about calibrating and validating equipment; maintaining clean facilities; training qualified employees; and demonstrating that our processes are reliable and reproducible, and that our validation methods have been tested and re-tested.

But even if those expectations weren’t regulated, GMP is simply good business practice. We need to know what we are doing, how we are doing it, be able to document it, and then figure out how to make it all better. This is what any good businessperson does to keep the enterprise running smoothly and in the most profitable way possible. So in response to my fair colleague, who would abandon GMP if possible, I must humbly disagree."

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