WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval.
Prostate cancer affects roughly 1 in 9 American men in their lifetime, with 174,650 new cases reported each year. However, current prostate specific antigen (PSA) tests lack specificity, leading to overdiagnosis and overtreatment of inconsequential cancers. Cleveland Diagnostics Inc. is looking to change that with its IsoPSA assay, which just received a breakthrough device designation from the U.S. FDA. In clinical studies, the noninvasive, blood-based test has been shown to have higher accuracy than standard PSA tests.
UL LLC, of Northbrook, Ill., has concluded a two-year cooperative research and development agreement (CRADA) with the U.S. Department of Veterans Affairs (VA), a program that verified that the UL 2900 standard provides a more seamless cybersecurity blanket for connected medical devices. UL said this marks is an important step toward the development of cybersecurity tools that ensure that devices can be used without undue risk to patients.
LONDON – As the May 2020 deadline for complying with the EU Medical Device Regulation (MDR) looms large, companies have been handed a further requirement they must meet if their products contain certain phthalate plasticizers. Phthalates are widely used to make polymers, in particular polyvinyl chloride (PVC), flexible. That allows it to be shaped into intubation tubes, catheters, blood bags, ventilator masks and other health care products. But the chemical bonds between phthalates and polymers are weak, and it is known they can leach into blood and other liquids, as well as be released into patients through mucous membranes.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is taking regulatory action in relation to all un-implanted breast implants and tissue expanders sold in that country. Those actions include suspension and recall of products, removal from the market and additional requirements for supply of products.
The U.S. Department of Justice (DoJ) has taken action to tamp down on False Claims Act (FCA) lawsuits. However, according to attorneys with the law firm of Gibson, Dunn & Crutcher LLP, the courts have come to different conclusions as to whether federal attorneys have appropriately dismissed FCA cases, a development that opens a new area of concern for drug and device makers.
The U.S. FDA has posted its guidance agenda for this still-young fiscal year (FY), a list that covers topics such as Clinical Laboratory Improvements Amendments (CLIA) waivers. However, the agency appears to be concerned about a lack of compliance with Section 522 postmarket surveillance studies, as indicated by the inclusion of the related guidance in the high priority list for do-overs in fiscal 2020.
PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining quick U.S. FDA approval based on the early results.
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