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Cannabis Research Lights Finally Turn Green
DEA makes a move to help increase the availability of cannabis for medical research.
September 20, 2019
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
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
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
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What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in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
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
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
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
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
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
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
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
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
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
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
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
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
Drug Companies Transfer Patents to Native American Tribes
Questions swirl around the revolutionary practice, which is intended to simplify drug makers’ defenses of their patents, but may not be upheld as legally valid.
October 31, 2017
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