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Section: Industry News > Regulatory
Medical Device/Packaging
Illinois Now Requires Insurance Companies to Cover EpiPens
Illinois will become the first state to require insurance companies to cover EpiPen injectors for kids.
August 23, 2019
EpiPen / Image: Getty
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
Chlamydia Vaccine / Image: People
Regulatory
FDA: Don’t Drink Bleach to Cure Cancer or Autism
The FDA is warning people not to drink “Miracle Mineral Solution,” as it’s the same as drinking bleach and extremely dangerous.
August 20, 2019
Bleach / Image: FDA
Regulatory
FDA Demands 44 Vape Pods Cease Sales
The FDA continues its attack on vaping by telling manufacturers of dozens of vape pod and hookah products to stop selling items immediately.
August 15, 2019
FDA vs Vaping / Image: Getty Images
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
SoomSafety Mobile App for Medical Device Recalls
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FDA Intends to Deactivate Outdated Drug Listing Records as Supply Chain Security Step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
FDA Intends to Deactivate Outdated Drug Listing Records as Supply Chain Security Step
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
HDA Traceability Seminar Oct 2019
Pharmaceuticals
Aggregation Proves Beneficial in a Contract (and Compact) Pharma Facility
Implementing new equipment where space is at a premium, PCI was able to incorporate aggregation and decrease inconsistencies in reconciliation.
August 8, 2019
The user-friendly Antares system helps PCI save time.
Regulatory
Companies Stay Alert as There’s No Obvious Slowing at FDA
One might expect these to be sleepy times at the U.S. Food and Drug Administration, seeing as how its commissioner resigned in spring, and that it’s part of an administration that has a dogmatically anti-regulatory philosophy.
August 5, 2019
Eric Greenberg
Regulatory
FDA Science Forum: Sep. 11 and 12
Topics covered at ‘Transforming Health: Innovation in FDA Science’ will include labels, digital health, cannabinoids and more. It’s open to the public, industry and more. Register soon!
August 1, 2019
FDA Science Forum: Sep. 11 and 12
Pharmaceuticals
FDA Requires Black Box Warning for Pfizer Drug
Pfizer will be required to add a black box warning for Xeljanz, stating that patients who take it could experience a higher risk of blood clots or death.
July 31, 2019
Xeljanz Box / Image: Pfizer
Pharmaceuticals
Partnership to Develop a “Vein-To-Vein” Digital Supply Chain
Shared sources and knowledge will benefit cell and gene therapy players through standardization, scalability, and compliance.
July 31, 2019
Dr. Andreas Fischer, Werum IT Solutions, and Charles Mooney, Blood Centers of America, closing the agreement.
Regulatory
Live from AHRMM: 4 Healthcare Supply Chain Trends
86% say a UDI icon or the word “UDI” next to the barcode would make it easier to identify at the point of care. Also on the agenda: RFID tracking and product storage space concerns.
July 29, 2019
Lana Makhanik, COO and Co-Founder of healthcare IT company VUEMED, at AHRMM.
Regulatory
Batch 4.0
Food and pharmaceutical industries are adopting Industry 4.0 technologies to modernize manufacturing for both regulatory compliance and continuous improvement.
July 29, 2019
Pall is working on adding analytics into continuous single-use processes for biologic drug manufacturing. Source: Pall
Regulatory
E-Cig Companies Have 10 Months to Submit Applications to FDA
The FDA reduced the deadline for e-cigarette companies to defend why they should be able to keep selling their products.
July 24, 2019
Juul / Image: Juul
Regulatory
Healthcare Packaging’s UDI Resource Guide
The 2019 UDI Conference is over for this year, so where can device packaging professionals get the information they need to meet the UDI regulations right now? Use Healthcare Packaging’s UDI Resource Guide as a launch pad.
July 15, 2019
Healthcare Packaging’s UDI Resource Guide
Packaging/Filling
Sanofi Oral Suspension: From Blow/Fill/Seal to Robotic Palletizing
At Sanofi’s Origgio facility outside Milan, automated efficiency is the watchword when it comes to packaging Enterogermina Oral Suspension. Additional production capacity is in the works.
July 12, 2019
he Robocombi system mechanically picks the strips of bottlepacks from the conveyors they stand in and places them directly into the four parallel conveyor lanes leading to the packaging line.
Pharmaceuticals
First Baby Born From Transplanted Uterus From a Dead Donor
A new development in reproductive options gives infertile women due to uterine issues another chance to bear children.
July 12, 2019
The Cleveland Clinic Team / Image: CNN
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