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402 Results
Type: Article
Section: Industry News > Regulatory
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
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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
Speaking on sustainability at last year's the[PACK]out (from left): Lindsay Smaron, Samantha Smith, and Kevin Kane with Moderator Jamie Pero-Parker, PhD. Image: the[PACK]out
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
From Left: PDA Annual Meeting co-chair Amanda McFarland, MS; Julia Jenkins; and Kelly Baker.
Traceability/Serialization
Confusion Persists Surrounding Suspect and Illegitimate Product
Under DSCSA, some manufacturers and distributors are struggling to understand which situations require a 3911 notification.
March 13, 2023
Ambient Gettyimages 171271581 Smaller
Traceability/Serialization
Op-ed: Data Issues Abound as DSCSA Deadline Nears
Trading partners are working diligently to connect data systems in compliance with the Drug Supply Chain Security Act (DSCSA). But significant challenges remain ahead of the November finish line.
February 22, 2023
Under the DSCSA, a distributor cannot accept or sell a product beginning on November 27, 2023, if that product does not have transaction information with the product identifier in an electronic file that meets DSCSA requirements.
Medical Device/Packaging
Roundtable Ahead of Pharmapack Europe Talks Drug Delivery Trends
From patient-centricity in a connected world to holistic sustainability strategies and proposed MDR amendments, hear what consultants have to say about the changing medical device landscape in 2023.
January 20, 2023
Getty Images 1256125471
Traceability/Serialization
GS1 US: Why the Barcode Isn't Going Anywhere
"We’re thrilled to have deep collaboration with members like Amazon, which currently sits on our Board of Governors, to drive supply chain and ecommerce innovation while also meeting the growing needs of today’s connected consumer."
January 13, 2023
Case Label Dscsa Getty Images 142227992 633b801e2b111
Regulatory
Counting Down the Top 10 Articles of 2022 - #1: Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #1, from personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.
January 4, 2023
Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.
Materials
Counting Down the Top 10 Articles of 2022 - #7: Manage Challenges from the EU 536/2014 Clinical Trials Regulation
Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #7, we cover study startup timelines, expiry labeling on primary packaging solutions, and study administration methods.
December 27, 2022
Regulation EU No 536/2014 on clinical trials brings changes that will impact study startup processes and timelines, expiry labeling on primary and secondary packaging, and study administration methods such as direct-to-patient.
Packaging/Filling
Quotables and By the Numbers: November 2022
Quotes and stats on clinical trial demographics, modes of transportation, the personalized medicine market, and more...
November 21, 2022
Getty Images 1038859668
Regulatory
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
Proposed NDC segments and formats. Source: FDA
Traceability/Serialization
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 nonconforming trading partners.
October 14, 2022
HDA Traceability Seminar dispenser panel (from left): moderator Ronald Bone, HDA Consultant, Ronald N. Bone Consulting LLC; Ian Cannell, Kaiser Permanente; Lisa Schwartz, National Community Pharmacists Association; and Leon Nevers, H-E-B.
Traceability/Serialization
Experts Still Concerned About Exceptions Under DSCSA
Live from HDA's Traceability Seminar 2022: Data issues may cause double the product holdup when a mismatch of product and data are shipped.
October 13, 2022
From left at the HDA Traceability Seminar: moderator Anita T. Ducca, HDA; Matt Sample, AmerisourceBergen Corporation; Arthi Nagaraj, Sanofi US; Julie Malone, Value Drug Company; and Michael Mazur, Pfizer Inc.
Medical Device/Packaging
Initial Call for Papers! ASTM D10 and F02 Packaging Workshop in Denver
Save the Date: The workshop will take place April 19, 2023 in Denver, CO, with discussion to include case studies, regulations, and more. Submit 300-word abstracts to Workshop Co-Chair Henk Blom before October 18, 2022.
October 10, 2022
The ASTM D10 and F02 Packaging Workshop will be held April 19, 2023.
Traceability/Serialization
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
If wholesalers are unable to read serial numbers or case label information, that product will need to be quarantined, researched, and verified, causing a supply chain disruption.
Regulatory
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
From left, moderator David L. Chesney, MSJ, principal and general manager, DL Chesney Consulting, LLC with Francis RW Godwin, MBA, office director, OC, CDER, FDA; Daniel DeCiero, consumer safety officer, CBER, FDA; Lance M. De Souza, MBA, director, compliance branch, OMPTO, ORA, FDA; and Marea K. Harmon, consumer safety officer, CVM, FDA.
Regulatory
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
Dr. Peter Marks, MD, PhD, director, CBER, FDA.
Traceability/Serialization
UDI Implementation Highlights Global Challenges
Q&A: At times, the hardest parts of UDI implementation are not about data matrices and linear barcodes at all. Jay Crowley talks global databases, portfolio management, and workforce issues.
July 25, 2022
Some manufacturers continue to use proprietary barcodes for various purposes that existed before UDI along with a UDI barcode. This can confuse downstream users. [Getty]
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