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Type: News

Section: Industry News > Regulatory

Institute calls for label symbol, funding, and reorganization to fix drug safety

More and more people are beginning to think that the FDA system for assuring the safety of drugs--especially new drugs--is broken.

October 24, 2006

Adherence/Delivery

RFID breaks new ground in clinical trial packaging

A macrolide azithromycin chronic obstructive pulmonary disease (COPD) Phase III study is using Med-ic RFID smart sensors embedded in blister packs. Sponsored by the National Institute of Health, the multiyear, double-blind study will enroll more than 1,100 patients at 10 clinical centers across the country.

July 10, 2006

Labeling/Printing

New Rules For Patient Package Inserts

In June, new Food and Drug Administration rules for the format and content of patient package inserts in prescription drugs became effective. The new format emphasizes "highlights" of the label information, provides a table of contents, requires the information to appear in a different order, and sets forth specified graphic requirements. That goes along with a requirement put in place late last year calling for drug makers to submit labeling information in electronic format, for easier searching and cross-referencing. Says the FDA, "These revisions will make it easier for healthcare professionals to access, read, and use prescribing information, and will enhance the safe and effective use of prescription drug products."

July 10, 2006

Medical Device/Packaging

FDA Analyst Delivers Medical Device Labeling Insights

At a June 6 Medical Design & Manufacturing East conference session, Food and Drug Administration regulatory policy analyst Arthur Yellin offered the following advice on medical device labeling:

July 10, 2006

Regulatory

RFID: Item-level tagging accelerates for pharmaceutical packaging

Crucial decisions need to be made by drug companies now, insists the CEO of a silicon chip maker.

July 10, 2006

Regulatory

Using packaging to build consumer trust for Internet drug purchases

In conducting research for his presentation at the recent HealthPack 2006 conference in Dallas, Joe Kornick "found a real and growing need for medical and pharmaceutical companies to give special consideration to their Internet packaging."

June 10, 2006

Medical Device/Packaging

Medical device packaging validation

Among the event's highlights is a new U.S. Pharmacopeia 1083 guidance chapter aimed at pharmaceutical counterfeiting in the supply chain.

May 10, 2006

Medical Device/Packaging

What ISO 11607 revisions mean to you

Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new International Standards Organization (ISO) 11607-01. Therefore, confusion may arise over certain areas of responsibility such as: • Who should test the packaging suppliers' seals? • Who is responsible for validating package sealing equipment? • Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?

May 10, 2006

Regulatory

Healthcare packaging news: By the numbers

$199.00 ... The cost for the Institute of Validation Technology's Special Report: An FDA Conference Report. The volume covers everything from validation to risk assessment to cGMP compliance to what's expected during an FDA inspection.

May 10, 2006

Labeling/Printing

Software aids labeling for clinical trials

When Specials Clinical Manufacturing opened its facility in Northumberland, United Kingdom, it needed a validated label printing system to manage recordkeeping and print labels for clinical trial packs. "Initially, there was no suitable system in place for printing labels, especially labels for randomized studies and projects," says Elaine Mackie, packaging manager at Specials, a custom drug maker and provider of packaging services for clinical trials. In need of a system that would meet GMPs and 21 CFR Part 11 regulations, Specials installed PrisymID Inc.'s Medica software with ClinTrial, an add-on module for clinical trial label printing management.

May 10, 2006

Regulatory

Risk assessment: A step-by-step process

Interphex New York presenters Gary Lynch of Eli Lilly & Co. and Terry Petro of Bosch Packaging Technology recommended beginning with the finished product in mind, including risk assessment of packaging and labeling. Here are the key steps:

May 10, 2006

Regulatory

JETT model leads to proactive decisions

One of the most basic problems of controlling the costs of manufacturing and packaging pharmaceuticals has been lack of risk assessment. Until lately, pharmaceutical companies have been spending top dollar on equipment and systems to take into account every possible scenario to try to alleviate the probability of anything bad ever happening.

May 10, 2006

Regulatory

ISO 11607 revisions: What they mean for packagers

Approval and publication of a revised ISO 11607 standard was expected this month, incorporating the provisions of the EN 868-1 standard. (Part I of II) The International Standards Organization (ISO) 11607 standard is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout manufacturing, shipping, and storage environments. Medical device manufacturers and packaging professionals should take note of the upcoming revisions to the ISO 11607 standard, as the revisions could mean the difference between pass or fail when it comes to package validation. Many terms have been added or eliminated from the current standard, including the following: • The definition of "medical device." ISO 11607-01 includes some medical devices that were not previously covered by the old standard. • "Primary package" is replaced by "sterile barrier system," defined as the "minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of end use." • "Final package" is replaced by "package system," defined as "[the] combination of the sterile barrier system and protective package." This combined package could include the second sterile barrier, or outer package, in a dual pouch or tray; a paperboard carton or shelf box; and the shipping container. These all may combine to form the "package system." • The elimination of "package integrity," which was defined as "unimpaired physical condition of a final package." Now it is implied that package integrity is lost if the sterile barrier system is breached or does not "prevent the ingress of microorganisms to the product."

April 10, 2006

Regulatory

RFID: Combating counterfeiting

Packagers share enthusiasm at February's RFID World event in Grapevine, TX. Purdue Pharma's 60-day pilot of RFID- enabled OxyContin at the item level was summarized by Mike Celentano, the company's associate director, supply chain and RFID systems: "We had fantastic reliability—only 10 to 15 bad tags out of 230,000. We concluded that the fundamental building blocks for RFID-based serialized point-to-point e-Pedigree exists today." He said the company has an interest in case and pallet-level tagging. Ken Reich, TAGSYS marketing director, revealed that Pfizer's item-level RFID program for bottles of Viagra manufactured in France features Web-based authenticity that permits pharmacies to verify the Viagra it receives. Meanwhile, Randall Lutter, the U.S. Food and Drug Administration's associate commissioner, policy and planning, reminded attendees that, unlike overseas, counterfeit drugs in the United States are quite rare. He suggested that the rise in cases in 2004 to 58 versus 30 in 2003 may be due to awareness. Final figures for 2005 will see a decline, he said, thanks to proactive investigations.

April 10, 2006

Regulatory

FDA tasks expand as budget shrinks

Agency speakers also discuss quicker inspections and combination drugs Feb. 16-17 at the new Puerto Rico Convention Center. At Medical Device Puerto Rico, at least three FDA speakers were not shy about explaining that responsibilities for agency employees were increasing despite budget cuts. The clearest of these messages was delivered in a keynote address by Gary Dykstra, regional food and drug director for the FDA's southeast region. He pulled no punches in describing the federal government's growing financial commitment to homeland security and related issues, presumably at the expense of funding FDA efforts. Dykstra singled out the current administration, saying he hoped change would come with the next presidential election. At a conference called "Inspection Priorities, Warning Letters & Complaints," the FDA's Joseph Puleo noted that the agency "typically gives U.S. companies a week or two advance notice before coming to a plant for inspection." Of course, this provides a manufacturer time to prepare for the visit, but as Puleo says, "it also benefits the FDA in that it allows them to communicate with the company so that the appropriate plant personnel are on-site for the inspection."

April 10, 2006

Labeling/Printing

Pharmaceutical marking & integration line

Domino Amjet, Inc. offers complete track-and-trace line to the healthcare packaging industry.

April 10, 2006

Regulatory

Compliance software

MasterControl Inc. offer compliance software to the healthcare packaging industry.

April 10, 2006

Regulatory

RFID tracking and tracing

Nosco offers RFID Package Integration brand initiative for pharmaceutical, biotech, and medical device manufactures and distributors.

April 10, 2006

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