The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean when considering the number of issues facing the agency.
The U.S. FDA’s pre-certification (pre-cert) program for software as a medical device (SaMD) seemed to run out of steam before the COVID-19 pandemic arrived, but the FDA was always presumed to need help from Congress to roll out a permanent version. A session at this year’s MedCon suggests that there is still life left in the pilot version of the SaMD pre-cert program, a critical development given that the legislation for the device user fee program offers the FDA no new statutory authority for a novel software regulatory framework.
Pharmacy benefit managers (PBMs) were in the spotlight at a May 5 U.S. Senate subcommittee hearing on fairness and transparency in the prescription drug market, but lawmakers indicated they need to turn up the klieg lights of the FTC to penetrate the black box of PBM operations.
As the U.S. FDA transitions to another new commissioner, the number of approvals has dropped to the lowest levels in seven years and is 19% below those approved by this time last year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Access Vascular, Clarius.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agastiya, Aptose, Aribio, Astrazeneca, Beigene, Ilya, Ipsen, Neuromagen, Novartis, Phathom.
Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia.
Orthofix Medical Inc. continues to expand its bone growth product line with a new premarket approval from the FDA for its Accelstim bone healing therapy device. Indicated for certain fresh fractures and fractures that have not healed, the device uses low-intensity pulsed ultrasound to stimulate the natural healing process. The company plans to take a phased approach to the launch, which will begin within weeks.
Before filing financial statements with the U.S. SEC, public companies will need to think about how their business has been impacted by Russia’s invasion of Ukraine and, perhaps, update filings they’ve already submitted.
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
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