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158 Results
Type: Blog
Section: Industry News > Regulatory
Traceability/Serialization
Using Holography to Fight Pharmaceutical and Healthcare Brand Piracy
Column: New trends in pharma packaging follow developments in emerging markets, demographic changes and new technologies that include holography, says chairman of the International Hologram Manufacturers Association.
October 24, 2019
Holographic foils can be used to great effect to differentiate product at the point-of-sale.
Cannabis
Cannabis Research Lights Finally Turn Green
DEA makes a move to help increase the availability of cannabis for medical research.
September 20, 2019
Eric Greenberg
Supply Chain
DSCSA: Where Are We, and Where Are We Going?
Recapping current progress, the Nov. 2019 saleable returns deadline and the supply chain transformation expected in 2023.
September 17, 2019
DSCSA: Where Are We, and Where Are We Going?
Regulatory
Cosmetics Claims: Stay In Your Lane
Claims to alter one’s appearance are OK, but cosmetics that claim effect on structure or function the body are, legally, drugs.
May 14, 2019
Eric F. Greenberg
Nutraceuticals/Dietary
FDA Supplements its Efforts
One of FDA’s goals is to see to it that consumers can trust dietary supplements. Its recent actions against companies making false claims is one step in that direction.
February 18, 2019
Eric F. Greenberg
Regulatory
Shutdown Starts up Thought
Americans could think hard for the first time about the importance of various government functions when they lose non-essential activities.
January 17, 2019
Eric F. Greenberg
Traceability/Serialization
Pharma can be Instructive on Food Track and Trace
While saying 'serialization' is coming to food isn’t quite right, and in fact is fraught with pitfalls, looking to pharma for lessons learned still will be critical.
December 11, 2018
Jim Chrzan, VP, Content and Brand Strategy
Pharmaceuticals
Making a Plea for a Single Product Identifier
HDA’s response to FDA’s Draft on DSCSA Product Identifiers notes lack of time to respond. GTIN or NDC identifier, human-readable expiration date format also pose concerns.
December 4, 2018
HDA’s response to FDA’s Draft on DSCSA Product Identifiers identifies lack of time to respond. GTIN or NDC identifier, human-readable expiration date format also pose concerns.
Regulatory
Tobacco Pushes to the Front of the Line
A latecomer to FDA’s stable of responsibilities, regulation of tobacco aims to protect the public health, though these efforts are not without controversy.
October 26, 2018
Eric F. Greenberg
Pharmaceuticals
FDA’s Late Recommendation on Human-Readable Format
What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in advance of the November deadline.
October 3, 2018
What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in advance of the November deadline.
Pharmaceuticals
Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under a Serialization Regulation
Aggregation data is the only thing that will ease the burden of compliance for downstream trading partners in a serialized world, says RxTrace’s Dirk Rodgers.
August 21, 2018
View of a layer of pharmaceutical cartons inside a case. (Photo courtesy of Omega Design.)
Traceability/Serialization
Could Penny-Pinching on Labels Derail Your Serialization Investment?
Part II of a two-part series emphasizes the significance of labeling in serialization, aggregation, and in temperature-sensitive environments.
August 15, 2018
Supply chain infographic provided by Domino.
Medical Device/Packaging
Providers Get The Message
Though its regulatory focus is usually on medical products and their makers and sellers, when the need arises, FDA writes letters to health care providers.
August 13, 2018
Eric F. Greenberg
Regulatory
Ignore Law's Definition of Drugs At Your Peril
FDA Warning Letters asserting that a supplement is a drug point up the curious legal definition of “drug” and provide a useful reminder to others.
July 30, 2018
Laws & Effect
Cannabis
FDA on Marijuana-based Drug Approvals: Not So Fast
The agency says don’t get ahead of yourself if you want FDA to clear your new drugs made of cannabis; settle down and take your bureaucratic medicine.
July 23, 2018
Laws & Effect
Regulatory
And Now, Warning Letter Spam
FDA says, ‘Hey! I’m warning you: I’m not warning you!’
July 16, 2018
Regulatory
What If FDA Didn’t Pre-Approve Products At All?
Today, we noodle, just for fun, on what might happen if radical changes were made in FDA’s powers over drugs and devices.
July 11, 2018
Pharmaceuticals
FDA Takes More Active Role Regarding DSCSA
The agency, as well as the Healthcare Distribution Alliance and GS1 US, provide educational guidance for the pharmaceutical industry, notes RxTrace’s Dirk Rodgers.
July 10, 2018
The agency, as well as the Healthcare Distribution Alliance and GS1 US, provide educational guidance for the pharmaceutical industry, notes RxTrace’s Dirk Rodgers.
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