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172 Results
Type: Blog
Section: News
Pharmaceutical
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
Pharmaceutical
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
Regulatory
Quality Issues Trigger Company Action, and Misty Columnist Memories
Two long-ago encounters about commitment to quality rattle around my brain, so I want them to rattle around yours, too.
July 3, 2018
Regulatory
When Drug Shortages Arise, FDA Helps Nudge Industry and Patients
The agency can, and does, do a lot of coaching from the sidelines when shortages occur
June 21, 2018
Regulatory
Generic Drug Review Machinery Getting a Tune-Up
More generic drugs means more competition means lower prices and oh yeah, more packaging.
June 19, 2018
Regulatory
These Days, Drug Compounding and Outsourcing Facilities Get FDA Scrutiny, Too
As with other additions to FDA’s legal powers, this one followed a tragedy.
June 13, 2018
Regulatory
Online Drug Sales Give FDA a Pain
Especially when the products contribute to problems associated with opioid abuse.
June 6, 2018
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
Regulatory
Laws & Effect: Teething Products Make Agency Bare Its Fangs
FDA begins with more bark than bite and my question is, how many of these puns do you want?
May 31, 2018
Pharmaceutical
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
Package Design
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
Pharmaceutical
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
Regulatory
Laws & Effect: Weekly FDA Reports Bring Reminders of Packaging's Importance
If you get a look at FDA’s Enforcement Reports, don’t let the importance of packaging and labeling get lost in a fog of other details.
May 7, 2018
Nutraceuticals/Functional
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
Sustainability
Perspective: New Efforts in Sustainability
How is the healthcare packaging community making strides toward a circular economy?
April 28, 2018
Regulatory
Laws & Effect: Aiming to Protect Health, FDA Increases Aim at Tobacco
Though a relative newcomer to FDA’s jurisdiction, could its tobacco efforts have more widespread health benefits than drug approval, food safety, and other traditional roles?
April 25, 2018
Pharmaceutical
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
Logistics/Supply Chain
Unusable Barcodes Present Troubling Compliance Issue
GS1 US, AmerisourceBergen and McKesson assessment of DSCSA serialization implementation progress reveals barcode readability issues.
March 19, 2018
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