In seeming opposition to U.S. Trade Representative Katherine Tai’s support of a proposed compulsory World Trade Organization intellectual property (IP) waiver on COVID-19-related medical products, U.S. Vice President Kamala Harris signed onto the G20’s May 21 Rome Declaration that commits the member countries to work to defeat the pandemic within the current flexibilities of the TRIPS agreement by promoting voluntary IP licensing agreements, technology and knowledge transfers, and patent pooling on mutually agreed terms.
With the intense focus on developing COVID-19 diagnostics, sequencing tools, vaccines and treatments, the pandemic is having an outsized impact on the global development of drugs and devices to treat other diseases. Recent data show that more than 1,000 clinical trials worldwide remain disrupted by COVID-19, including 60% of the non-COVID-19 trials being conducted in the U.S., as funding and other resources continue to be directed toward ending the pandemic.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
The FDA’s November 2019 two-day hearing regarding the use of metals in medical devices generated at least one actionable recommendation, namely that manufacturers disclose all materials used in devices in product labels. The agency has reacted to that recommendation in the form of a discussion paper that proposes to require that product labels provide a deep level of detail regarding the materials found in the device, a notion that received the backing of industry during the November 2019 hearing.
PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Ito.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Hologic, Intersect ENT.
Motus GI Holdings Inc. received FDA 510(k) clearance to use its Pure-Vu system in upper gastrointestinal endoscopies, expanding the system’s indications from use only in colonoscopies. Pure-Vu removes blood, blood clots and debris from the GI tract, allowing endoscopists to see sources of bleeding and other issues while leaving the endoscope's working channel available for other uses.
With the next user fee agreement negotiations underway, device makers are not keen on a substantial hike in fee volumes. Nonetheless, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, has proposed a total product life cycle (TPLC) advisory function for the next user fee agreement, something he said would bring more predictability to industry and allow the agency to interact much more routinely with device makers.
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