Vol. 2, No. 27
| Thursday, July 3, 2008 | CDRH Pushing Industry on PMAP Inspections
Devicemakers that were invited to but did not participate in the joint U.S.-Canadian pilot multipurpose audit program (PMAP) are a priority for FDA inspection, according to an agency director. Under PMAP, firms audited by an accredited FDA inspector also satisfy the inspection requirements for Health Canada. The program is part of the FDA’s harmonization efforts for medical devices, which allow one inspection to fulfill regulatory requirements for multiple jurisdictions. The Center for Devices and Radiological Health (CDRH) looked at Health Canada’s list of planned audits for the next year and matched them up with sites the FDA was going to inspect, Timothy Ulatowski, director of CDRH’s Office of Compliance, said. Facilities scheduled for audits by both regulators were requested to participate in PMAP. “We had a few takers but not enough,” Ulatowski said last week at the FDAnews Medical Device Quality Congress in Cambridge, Mass. “We are going to inspect those people who do not take us up on that one audit.” The decision is not punishment for manufacturers’ lack of participation, Ulatowski said, because the companies were considered inspection priorities anyway. To guide the center’s selection criteria for which firms to inspect, the FDA plans to release a draft guidance explaining how the agency will interpret International Organization for Standardization (ISO) audits voluntarily submitted by manufacturers, Ulatowski said. Under the FDA Amendments Act, the agency is authorized to use submitted audit reports to help determine its inspection priorities. Surgical Tools Sterilized in Hydraulic Waste Result in Suit
Devicemakers Steris and Cardinal Health are facing a class action lawsuit after surgical instruments at two hospitals were sterilized in hydraulic waste fluid from elevators rather than Steris cleaning solutions. The mix-up occurred when an elevator company working for Duke Health Raleigh Hospital in North Carolina used empty sterilization fluid barrels to discard hydraulic waste fluid. The barrels were picked up by Cardinal, the sterilization fluid distributor, and were mistakenly restocked and shipped to Raleigh Hospital and Durham Regional Hospital. The hospitals used the fluid as part of their sterilization processes for surgical instruments in November and December 2004. An undisclosed number of affected patients reached a settlement last month with Duke University Health Systems, which operates the two hospitals. Settlement terms are confidential, HensonFuerst, the plaintiffs’ law firm, said. HensonFuerst also is representing 67 plaintiffs in the new suit, which was filed June 17 in Durham County Superior Court in North Carolina. These plaintiffs have developed various symptoms and injuries after exposure to the waste fluid, the suit claims. The complaint says Steris and Cardinal acted negligently in their handling of the incident. Cardinal should have refused the barrels as returns based on their condition, the lack of paperwork and safety seals and other circumstances, the suit says. It also alleges that Steris failed to respond properly to complaints from both hospitals about greasy, oily instruments coming out of the washers, thus violating its own policies. FDA’s Sentinel Initiative Will Not Burden Industry
The FDA’s launch of Sentinel, an initiative designed to transform the agency’s postmarket surveillance, will likely not place additional regulatory burdens on devicemakers, according to an agency director. “There won’t be more requirements because of the Sentinel effort,” Thomas Gross, director of the FDA’s Center for Devices and Radiological Health (CDRH) Division of Postmarket Surveillance, said. The program is designed to complement existing surveillance tools, such as postapproval studies and adverse event reporting systems. “We have requirements in place already,” Gross said, such as “adverse event reporting, where manufacturers are required to report device-related deaths, serious injury and malfunctions. We have requirements for so-called postapproval studies for high-risk devices. So we will continue to use those because they are very effective tools. … That won’t change.” In the first stage of the initiative, the FDA will have access to the Centers for Medicare & Medicaid Services’ database of Medicare Part D prescription drug claims. “We’ve done some pilot work in exploring the use of Medicare data, and we’d like to pursue that in the future … because it can be applicable to device safety issues,” Gross said. CDRH said once Sentinel is up and running, the FDA will be able to query specific adverse event data in large databases containing claims or electronic health information maintained by private and federal organizations that agree to participate in the program. However, “this capability will not be fully realized until unique device identifiers are established and incorporated into these databases,” CDRH said. | Navigating the FDA's New Requirements for eCTD Submissions
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Bayer Acquires Topsun Portfolio
Bayer HealthCare (BHC) announced that BHC's Consumer Care Division has achieved the necessary regulatory approvals to complete the acquisition of the Western over-the-counter (OTC) cough and cold portfolio of Topsun Science and Technology Qidong Gaitianli Pharmaceutical Co., Ltd by Bayer Healthcare Company Limited in China.
finchannel.com Progen Pharmaceutical Manufacturing Arm to Stand Alone
Brisbane-based Progen Pharmaceuticals Limited announced the "spin-out" of its manufacturing business as the wholly owned subsidiary company PharmaSynth Pty Ltd. The launch of PharmaSynth will allow the new company to focus on the provision of contract pharmaceutical development services.
qbr Cantel Medical to Move Dutch Operations to U.S.
Cantel Medical, a provider of infection-prevention products, said its Minntech Corp. subsidiary will move all of its Dutch manufacturing operations to the United States.
Boston.com 55 New Jobs Coming to North Carolina
A Virginia-based pharmaceutical company is opening a plant, creating 55 new jobs. Galexe Pharma Sciences, a subsidiary of Excela PharmSci Inc., is investing $8.6 million in the plant over the next three years.
Hickory Daily Record CytoDyn Begins GMP Manufacturing of AIDS Drug
CytoDyn has begun GMP manufacturing and humanization of Cytolin, a monoclonal antibody that uses the human immune system to control HIV infection.
Yahoo! Finance Breakthrough Imtech in Belgian Pharmaceutical Market
Imtech will realise much of the technology in the CDPP project (Chemical Development Pilot Plant) in Geel for Janssen Pharmaceutica (part of the American pharmaceutical group Johnson & Johnson). This high-tech plant will play a pivotal role in reducing the time it takes to develop new medicines.
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