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159 Results
Type: Blog
Section: Industries
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
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
Pharmaceuticals
3 Air Cargo Trends Shaping Pharma Transportation
In 2019, blockchain, Artificial Intelligence, and external market forces—such as pilot shortages and sea freight challenges—will shape air cargo trends.
January 23, 2019
In 2019, blockchain, Artificial Intelligence, and external market forces—such as pilot shortages and sea freight challenges—will shape air cargo trends. (Pelican BioThermal)
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.
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What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in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What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in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.)
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
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
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.
Pharmaceuticals
No Shortage of Creative Solutions
Drug shortages can have serious health effects, but early notifications from manufacturers and creative and flexible FDA actions are making a dent.
July 6, 2018
Eric F. Greenberg
Cannabis
Perspective: Patient Access Increases for Medical Marijuana
The healthcare packaging community has an important role to play in the medical marijuana patient experience.
June 1, 2018
Perspective: The healthcare packaging community has an important role to play in the medical marijuana patient experience.
Pharmaceuticals
Laws & Effect: Are New Drug Approvals Going Out of Style?
FDA clearance of specific drugs for specific uses is increasingly seen as in conflict with free speech rights, and change might come soon.
May 21, 2018
Laws & Effect
Materials
Laws & Effect: Streamlining for Combination Products: Please, May I Have Some More?
Sure, FDA has proposed to help speed their reviews of new products that combine categories, but will it really get out of its own way?
May 16, 2018
Laws & Effect
Pharmaceuticals
Barcode Integrity Crucial for Brand Authentication, Anti-Counterfeiting and Regulatory Compliance
Industry assessments are demonstrating that using verifiable, standards-based barcodes to improve traceability, block counterfeits and address regulation requirements will also enable operational, economic and patient safety improvements.
May 15, 2018
A barcode assessment conducted by AmerisourceBergen and McKesson Pharmaceutical, in collaboration with GS1 Healthcare US—just six months before the November 2017 deadline—found only 6.6 percent of 16,618 pharmaceutical packages scanned met the DSCSA requirement for a readable barcode with four data elements.
Nutraceuticals/Dietary
Laws & Effect: Caffeine Cometh, But Not Always Safely
FDA’s action – well, guidance – about concentrated caffeine in dietary supplements shows that even common substances might not always be safe, but packaging might be a key solution.
May 1, 2018
Laws & Effect
Pharmaceuticals
A Regulator in an Anti-Regulation Era
Bucking the trend, it appears Scott Gottlieb’s FDA is protecting the public health and trying to make it easier to clear new medicines and devices quickly.
April 24, 2018
Eric F. Greenberg
Cannabis
Pot (Policy) Causes (More) Disorientation
In a realm already marked by inconsistency and uncertainty, the Trump administration makes a surprise change in policy that only adds to the confusion.
January 12, 2018
Eric Greenberg, Legal + Regulatory Columnist
Medical Device/Packaging
Focus on Data Quality to Prepare for Class III UDI Implementation
Medical device firms need to consider their data strategy and ensure the right structure is in place for establishing clean UDIs in order to contribute to patient safety.
November 3, 2017
Medical device firms need to consider their data strategy and ensure the right structure is in place for establishing clean UDIs in order to contribute to patient safety.
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