The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence, said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well.
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product. The supporters of the legislation, a bipartisan group of members of the House Energy and Commerce (E&C) Committee, see the legislation as essential as a means of overcoming some of the ambiguities in a 2018 FDA guidance pertaining to communications between manufacturers and payers, and thus a replay of one of the more interesting methods of critiquing an FDA guidance.
The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence (OCE), said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well. Pazdur said OCE and the FDA’s Center for Devices and Radiological Health are working on a pilot program that would entail the publication of performance standards for the tests used in these trials, a development that would lead to more routine development of lab-developed tests (LDTs) for these studies and thus undercut any incentive to develop a patented in vitro diagnostic for that purpose.
The U.S. FDA has finalized a rewritten draft guidance for Section 522 postmarket surveillance studies, a policy that carries a new level of stringency regarding how these studies are conducted. The final guidance calls for all subjects in such a study to be enrolled within 24 months, a deadline some in industry argued might prove unduly burdensome in some instances.
The problem with notified body (NB) capacity in the European Union is well known, but a recent survey of NBs suggests that more than 17,000 certificates for medical devices and active implanted devices issued under the legacy regulation are set to expire by the end of 2024. More troubling might be the fact that the number of standing applications dwarfs the number of completed applications by a ratio of more than four to one, a gap that continues to grow as calendar year 2022 unwinds.
Cybersecurity has become one of the core concerns for med tech in this part of the 21st Century, and a collaboration between the FDA and the Mitre Corp., has yielded a new playbook that calls for a regional response to issues such as ransomware. However, this new document calls on medical device manufacturers to take part in cybersecurity exercises along with health care delivery organizations, an exercise that some manufacturers might not be prepared to undertake.
The U.S. Department of Health and Human Services (HHS) has issued a bulletin in connection with the Venus ransomware, the latest in a running series of such malware to hit computer systems across the globe.
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe Holding Co., which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful.
Patients with ophthalmic disease use eyedrop containers and eyecups millions of times a year, but these two devices have been treated as one device type and informally regulated as class II devices up to now. A U.S. FDA advisory committee recommended a class I designation for these products, which will relieve some of the burden on manufacturers, but the panel also endorsed that these two types of products be split into two separate product codes, which would greatly facilitate adverse event reporting.
The U.S. FDA has wrapped up its guidance effort to deal with counterfeit devices, an effort that consumed roughly 11 months. That span of time had little discernible effect on the draft, however, as the final guidance seems to leave the draft’s explanation that future FDA guidances may refer to more than one section of the statute in references to the definition of a device.
