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Regulatory: Page 26
Pharmaceuticals
Cancer-Linked Contaminant Found in Heartburn Pills
Low levels of NDMA have been found in samples of the heartburn medication Zantac, according to the FDA.
September 18, 2019
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
Nutraceuticals/Dietary
Grass-to-Glass Traceability and Consumer Engagement for Infant Formula Brand, Friso
Kezzler enables FrieslandCampina to reinforce transparency and build trust with Chinese consumers.
September 9, 2019
Traceability/Serialization
Company Reports Three out of Ten 2D Barcodes Failing, Letter Stresses Saleable Returns Challenges
Returns verification requirement deadline is approaching fast.
September 5, 2019
Regulatory
Healthcare Compliance Packaging Council Comments on FDA's Look at Unit of Use Blister Packaging for Certain Opioids
The Council notes that limited doses in properly designed blisters will not only mitigate overuse, but also limit excess unused doses—frequently the source of diverted and misused pills.
August 27, 2019
Cannabis
Update: DEA Plans to Expand Marijuana Research
“DEA anticipates that registering additional qualified marijuana growers will increase the variety of marijuana available for these purposes,” said DOJ announcement.
August 26, 2019
Pharmaceuticals
Schreiner MediPharm: Forensic Counterfeit-Proof Feature for Pharma Labels
SigNature DNA is a high-security feature based on DNA markers to prevent counterfeiting and which can be used as evidence in courts of law.
August 26, 2019
Pharmaceuticals
First Clinical Trial for Chlamydia Vaccine Looks Promising
The first ever vaccine for chlamydia has proven safe and effective in initiating an immune response in early trials.
August 21, 2019
Medical Device/Packaging
New Mobile App Notifies Patients, Caregivers, and Nurses of Medical Device Recalls
Using barcode and knowledge graph technologies, the app sits on top of all other databases to provide complete and current information to users.
August 14, 2019
Regulatory
FDA Intends to Deactivate Outdated Drug Listing Records as Supply Chain Security Step
“The agency has found that tens of thousands of drug listing records have not been updated or certified in the past year, and are therefore not in compliance with federal regulations…”
August 13, 2019
Traceability/Serialization
Antares Vision: Traceability System with Consumer Engagement Capabilities
TrackMyWay platform offers supply chain transparency through stakeholder communication, and customer engagement.
August 12, 2019
Pharmaceuticals
Work Through Common Implementation Challenges at HDA’s 2019 Traceability Seminar
Washington, D.C. hosts this year’s event that will feature a forum for stakeholders to plan for and discuss current and future milestones and challenges.
August 9, 2019
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Top Stories
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Manufacturers who treat ISO 11607's worst-case clauses as a risk-management tool, rather than a box to check, are far better positioned to keep their packaging, and their products, performing as intended.
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