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1,882 Results
Section: Industry News > Regulatory
Traceability/Serialization
Antares Vision Group Attains ISO/IEC 27001 Certification
Antares Vision Group
Obtained through rfxcel, the information security management systems certification demonstrates the group’s ability to protect and manage customers’ data on a global scale, complementing rfxcel’s ISO 9001 certification.
July 12, 2023
Cannabis
FDA, FTC Warn About Selling Copycat Products Containing Delta-8 THC
FDA
Six companies have been told to stop selling products that use similar brand names, logos, or pictures on packaging to mimic well-known snack food brands.
July 10, 2023
Traceability/Serialization
Op-ed: Phased Approach to DSCSA an Alternative to Nov. 27 Disruptions
The pharmaceutical supply chain is not where it needs to be as the DSCSA deadline approaches. A new approach is necessary to ensure the safe and secure delivery of medicines come November.
July 6, 2023
Logistics
HDA Traceability Seminar (Aug 29-31, 2023) and Webinar Series
Healthcare Distribution Alliance (HDA)
With Nov. 2023 approaching, HDA is holding its in-person Traceability Seminar two months early—in August—in Washington D.C., after its 3-part summer webinar series, covering tech solutions, industry recommendations for DSCSA enforcement, and more.
June 27, 2023
Labeling/Printing
Supplement Brand Lifeplus Brings Label Printing In-House for 400+ Products
To eliminate the inefficiencies of outsourcing, Lifeplus implemented digital label presses to handle over 400 product labels in 22 different sizes, offering a simple, streamlined, and automated approach to consistent label printing.
June 19, 2023
Traceability/Serialization
Live from GS1 Connect: J&J Beating 2027 Sunrise on UDI
The healthcare giant continues its nine-year migration from UDI to 2D GS1 DataMatrix.
June 8, 2023
Regulatory
FDA Issues Pediatric Drug Development Draft Guidance
FDA
The new draft guidance assists industry members in obtaining the data and information necessary to support the approval of drug products in pediatric populations.
May 24, 2023
Temp Control/Cold Chain
Merck Expert Shares 5 Tips for Qualifying Pallet-Sized Thermal Shippers
Find out why Lee Menszak advocates for shipper-to-shipper variability testing from his talk at ISTA’s TempPack event.
May 24, 2023
Medical Device/Packaging
RRD Simplifies Medical Device Recall Notices
RRD (R.R. Donnelley & Sons)
Speed, patient safety, and compliance are key drivers in a new recall notices solution designed to support medical device companies and their need for immediate response.
May 15, 2023
Regulatory
FDA Taking Steps to Advance Decentralized Clinical Trials
FDA
The agency’s newest draft guidance supports the use of DCTs for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
May 11, 2023
Medical Device/Packaging
Breakthrough Med Device Sterilization Technology Uses Nitric Oxide
Not to be confused with laughing gas, this “molecule inside a polymer” is poised to offer safe sterilization of medical devices to kill microorganisms without the environmental issues brought by EtO sterilization.
May 10, 2023
Medical Device/Packaging
Spotlight on Sustainability at the[PACK]out
Happening at the[PACK]out: Get the latest on advanced recycling, the realities of medical package recycling, challenging the status quo, and more. The conference takes place May 9-11, 2023, in Austin, TX.
April 26, 2023
Regulatory
FDA Requiring Mail-back Envelopes for Opioid Analgesics
FDA
All manufacturers of opioid analgesics used in outpatient settings will be required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the FDA’s notification letter.
April 6, 2023
Regulatory
Rare Disease Patient and Advocate Talk Actions You Can Take
“We don't believe patients should have to start their own drug company to save themselves or save their child,” says Julia Jenkins, policy expert, at the PDA Annual Meeting.
April 3, 2023
Regulatory
FDA Issues Guidance for Cybersecurity of Medical Devices RTA Policy
FDA
The document addresses the Consolidated Appropriations Act, 2023, Ensuring Cybersecurity of Medical Devices section’s refuse to accept policy for cyber devices and related systems.
April 2, 2023
Regulatory
FDA Issues Guidances for Medical Device Transition Plans
FDA
The agency has issued the documents to assist with transition plans for COVID-19-related medical devices.
March 28, 2023
Nutraceuticals/Dietary
Jones Healthcare Set to Help Nutraceutical Brands Meet New Canadian Regulations
Jones Healthcare Group
The company’s investment in a Gallus Labelmaster 440 label press from Heidelberg supports Canada’s extended content requirements.
March 22, 2023
Traceability/Serialization
Antares Vision Group Partnering With Renown Health Network
Antares Vision Group
rfxcel, part of Antares Vision Group, will implement DSCSA compliance solutions to help ensure pharmacies across the northern Nevada healthcare network comply with the regulations.
March 16, 2023
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