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Machinery & Materials
Logistics & Cold Chain
FDA Issues Draft Guidance on Breakthrough Devices Program
The goal of the updates is to reduce existing disparities in health and healthcare in the U.S.
November 14, 2022
FDA’s Proposed Change to NDC: Comments Due Nov. 22, 2022
The NDC proposal is intended to minimize the impact of “running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.”
November 1, 2022
How Missing Traceability Data Might Affect Pharmacy Patients
If accurate and complete pharma traceability data isn't supplied to pharmacists, they may end up scrambling to serve the patients in front of them. Pharmacy leaders discuss how this may affect relationships with misbehaving suppliers.
October 14, 2022
DSCSA: Labels Practically as Important as the Medicine Itself
In becoming compliant with interoperable data exchange requirements under DSCSA, don’t overlook the pharmaceutical label itself. Missing case labels or faded inks can pose threats.
October 4, 2022
FDA Lists Mechanisms to Comply With CGMP Requirements for CPs
While the FDA has provided examples of mechanisms, CP manufacturers should consider the suitability of an approach in the context of their product and manufacturing process.
September 19, 2022
FDA Issues Medical Device Production Computer Software Guidance
The draft guidance provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
September 15, 2022
Improve Responses to 483s by Expanding Your Focus
FDA audit observations happen in life science manufacturing. When an issue is found, FDA will be looking to determine if the finding is a one-off, or whether it’s the tip of the iceberg.
September 15, 2022
FDA Perspective: COVID-19 Learnings in Communication, Manufacturing
Dr. Peter Marks: “One thing we definitely learned does not work: you can't keep cold capacity. If you have a facility that's completely cold… then you want to try to bring it up to manufacture vaccines, it just doesn't work well.”
September 12, 2022
2022 PDA Pre-Filled Syringes Conference and Parenteral Packaging Courses
Held in Palm Springs, CA, the in-person conference takes place Oct.18 - 19 and the courses follow on Oct. 20.
August 22, 2022
FDA Finalizes Instructions for Use Guidance
The document clarifies IFU labeling for pharmaceutical manufacturers to help consumers understand complicated instructions when using a drug or biologic.
August 2, 2022
FDA Releases Draft Guidance on Use of Remote Regulatory Assessments
The guidance covers voluntary and statutorily authorized RRAs, but does not change the core requirements of inspections and pre- and post-market authorities.
July 26, 2022
HDA Traceability Seminar in D.C. PLUS Webinar Series
HDA will hold a webinar series (August 11 and 25 and September 15 and 29) prior to the in-person Traceability Seminar taking place October 12 to 14 in Washington D.C. Sessions will cover DSCSA, EPCIS, wholesale distributor services, VRS, and more.
July 22, 2022
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Q&A: Foil Tariffs Pose Imminent Threat to Healthcare Costs, Lead Times
In this Q&A, we talk with PAXXUS' Dwane Hahn about the serious supply chain continuity implications that loom as the packaging community awaits a scheduled decision from the Department of Commerce on December 15, 2022.
MassRobotics Names Participants in Healthcare Robotics Startup
Quotables and By the Numbers: November 2022
Haleon, Microsoft Enhance Product Accessibility for Vision Impaired
Gel Packs in Recycle-Ready Film
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RFID Tag Encoding and Logging Solution
The Sato and Loftware cloud-based solution helps producers of medical devices and pharmaceuticals meet stringent traceability requirements.
Tablet Press Solution
Connected Printer Services
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Triumphs and Challenges in Sustainability
Healthcare Packaging News Roundup: Sustainability
Healthcare Packaging's Most Popular Articles
Healthcare's Sustainability Approach: Waste Reduction
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