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Type: News

Section: Industry News > Regulatory

Protection from lawsuits: Devices yes, drugs no

A U.S. Supreme Court decision offers a reminder that drug manufacturers, not the FDA or others, are responsible for product safety.

April 29, 2009

Packaging/Filling

Improving tablet production and handling

Vacuum technologies can streamline production, reduce costs, and provide sustainability benefits. Sidebar story describes how Surepharm Services benefits from vacuum technology (shown in photo).

April 24, 2009

Materials

Bauer's pharmaceutical handbook lends 'Hall of Fame' packaging perspective

Professionals and students will benefit from an informative research tool now available for the healthcare packaging community.

April 10, 2009

Labeling/Printing

Drug makers not preempt from lawsuits

U.S. Supreme Court decision offers a reminder that drug manufacturers, not the FDA or others, are responsible for product safety.

March 29, 2009

Sustainability

Four pharmaceutical plants earn EPA's Energy Star

During Interphex 2009, held March 17 - 19 in New York, the U.S. Environmental Protection Agency recognized the first four pharmaceutical facilities to earn the agency's Energy Star, given to companies that perform in the top 25% of energy use nationwide.

March 29, 2009

Medical Device/Packaging

Eastman launches Tritan medical-grade polymers at MD&M West

At a February 11 trade press breakfast, Eastman Chemical Co. announced that it is launching medical grades of its Tritan copolyester. Scott Hanson, the company's global industry leader, noted that Tritan was introduced in late 2007 to consumer markets for use in reusable sports water bottles, infant care, and houseware products. Now Tritan is being aimed at applications such as IV system components, and respiratory and blood therapy devices, offering a balance of design, molding, and end-product properties for medical devices. Eastman plans to sell Tritan resin to both injection-molders and directly to medical device manufacturers that have in-house injection-molding capabilities.

February 11, 2009

Adherence/Delivery

McKesson, Burgopak team up on compliance packaging in the U.S.

February 3, 2009

Adherence/Delivery

Brazilian patent given for pharmaceutical dosing system

AccuDial Pharmaceutical announced that the Brazilian Patent and Trademark Office issued patent No.

January 30, 2009

Adherence/Delivery

GlaxoSmithKline, Abbott, and contract packaging panel highlight Pharmaceutical Packaging Forum

The third-annual Pharmaceutical Packaging Forum (PPF) will deliver information you can use on pharmaceutical package design, increasing quality and productivity, patient compliance, strategies to combat counterfeiting, how to increase packaging line profitability, and will include a contract packaging panel, and a session on equipment risk assessment. This story provides an overview of some of the sessions scheduled for the April 15 PPF in Philadelphia:

January 22, 2009

Medical Device/Packaging

Three testing tips for medical device packages

Sterile medical device package testing is a requirement for compliance to ISO 11607 "Packaging for Terminally Sterilized Medical Devices", Part 1: Requirements for materials, sterile barrier systems and packaging systems, and Part 2: Validation requirements for forming, sealing and assembly processes. The following three tips help ensure that your medical package system is evaluated and ultimately validated with the most appropriate, relevant testing protocols for validation of sterile barrier integrity and overall package and product safety and efficacy.

January 5, 2009

Adherence/Delivery

Cost pressures cloud healthcare packaging's future

Mounting financial pressures top a list of issues driving the pharmaceutical, biologic, and medical device sectors. In an exclusive interview, Freedonia senior healthcare consultant Bill Martineau discusses where packaging fits into these issues. Even before the recent global financial turmoil, pharmaceutical, biologic, and medical device manufacturers faced considerable economic pressures. Corporate efforts to control costs continue to trickle down to the packaging function, with packaging line efficiencies more closely scrutinized, and material decisions made based on performance and economics.

December 18, 2008

Pharmaceuticals

Packaging vaccines for pandemic flu or bioterrorist attack: Are we ready?

A Congressional blue-ribbon panel believes, "Terrorists are likely to use a weapon of mass destruction somewhere in the world in the next five years," according to a Dec. 2 CNN report. Biological weapons are more readily available than nuclear devices, and their attacks would be easier to carry out, notes former Senator Bob Graham in the report. From a packaging perspective, are we ready for such an attack? Healthcare Packaging publisher Jim Chrzan addresses the issue, based on a recent International Society for Pharmaceutical Engineering annual meeting session that dealt with offering rapid response for vaccine creation for a pandemic flu or bioterrorist attack.

December 15, 2008

Pharmaceuticals

Podcast: Serialization matters: What pharmaceutical packagers need to know

In this exclusive podcast from Pack Expo 2008, Anne Marie Mohan, senior editor of Packaging World, speaks with Bruce A. Harder, Systech International's director of business development. Harder provides an overview on what constitutes a complete serialization solution and advises packagers on how to equip their new packaging lines with serialization in mind. Whether it's for track-and-trace purposes or for brand protection, serialization is becoming an important packaging process, particularly in the pharmaceutical market. But what does serialization comprise? Is it a single unique code on a package? Or can it go beyond authentication to integrate with a brand owner's business systems?

December 15, 2008

Package Design

Pack Expo podcast: Sorbents factor into life science packaging

One-day workshop Jan. 18, 2017 is designed to help prepare manufacturers, wholesale distributors and healthcare providers to meet DSCSA requirements.

December 15, 2008

Adherence/Delivery

CHPA issues voluntary pediatric cough and cold label updates

"Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral pediatric cough and cold medicines with new labels and packaging. As with other OTC [over-the-counter] labeling changes in the past, FDA [U.S. Food and Drug Administration] has indicated it does not believe this labeling change warrants the removal of products with the existing labeling from store shelves during this time of transition." These remarks stem from an October statement issued by Linda Suydam, president of the Consumer Healthcare Products Assn.

December 15, 2008

Regulatory

FDA enforcement and activity may rise in new administration

Controversies about drug reviews and clearance continue, while preemption and drugs could potentially change the legal landscape for industry and consumers.

December 15, 2008

Adherence/Delivery

DPT, Med-Health Pharma shed light on authentication solutions

A pervasive air of secrecy makes trends in brand protection tough to track. But the following two pharmaceutical-based authentication efforts by DPT Laboratories and Med-Health Pharma shed light on some of the solutions being explored to combat counterfeiters, diverters, and gray marketers who appear to be broadening their horizons, reports Pat Reynolds, Editor, Packaging World magazine. Alan Green, logistics director for DPT Laboratories, will discuss how the contract developer, manufacturer, and packager is implementing brand-protection strategies at the Brand-Protection Packaging Forum May 5, 2009 in Chicago.

December 11, 2008

Adherence/Delivery

California e-Pedigree delay provides temporary relief

Uncertainty colored most discussions at a recent healthcare track-and-trace conference, reports contributing editor Steve Barlas. A key question: How will FDA actions differ from California's e-Pedigree program? It was clear that packagers attending the "RFID Track and Trace" conference sponsored on November 16-18 by the Healthcare Distribution Management Assn. and the National Assn. of Chain Drug Stores were breathing a sigh of relief now that California has (again) delayed implementation deadlines for its mass serialization/e-pedigree requirement.

December 1, 2008

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