“The FDA is keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruption to supplier shortages of critical medical products in the U.S.,” FDA Commissioner Stephen Hahn said Tuesday, Feb. 25, during a Department of Health and Human Services (HHS) briefing on the COVID-19 outbreak.

During a conference call with investors, Baudax Bio Inc. CEO Gerri Henwood let out an exuberant “woohoo!” to celebrate the FDA’s approval – after two turndowns and much haggling over data – of Anjeso (meloxicam) for moderate to severe pain. Echoing her sentiment was Piper Sandler analyst David Amsellem. “It’s nice to see the pain division finally get this one right,” he said.

Medical device companies are seeking to reduce product defects and increase patient safety with an industry-managed program that focuses on final product quality via oversight of the most critical manufacturing processes. Modeled on a 30-year-old aerospace industry program called Nadcap, Medaccred brings device manufacturers and suppliers together to define accreditation for special processes.

The response from industry regarding the Environmental Protection Agency’s (EPA) draft rule for ethylene oxide (EtO) varied considerably, but the Advanced Medical Technology Association (Advamed) argued a fundamental methodological point in its comments to the docket. Advamed’s Ruey Dempsey said the EPA approach to determining safe levels of EtO relies on “a single epidemiological study,” an approach Dempsey said has drawn fire from the National Academies of Science.

The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable.

Medtronic plc, of Dublin, blamed dampened demand for heart devices ahead of new product launches for its third-quarter revenue miss. Fiscal 2020 Q3 revenue totaled $7.72 billion, below Wall Street’s estimate of $7.81 billion, for organic sales growth of 2.6% vs. consensus and guidance of 4% or higher.

Fisher Wallace Laboratories of New York has filed a citizen’s petition with the U.S. FDA regarding the agency’s proposed class III designation for cranial electrotherapy stimulators (CES) for treatment of depression. The company argued that the agency disallowed evidence at an advisory hearing regarding this therapy provided by direct rather than alternating current, but also that the FDA had reneged on an earlier decision to classify these devices as class II devices.

SEATTLE – Tracing the family tree of COVID-19 through its evolving DNA sequence makes it possible to disprove many false claims circulating on social media about the novel coronavirus, and, in particular, that it was generated in a covert biological weapons program.

ANAHEIM, Calif. – Most medical device manufacturers follow a traditional, linear, task-driven approach for product development. Switching to a knowledge-driven approach, called agile-lean, may yield better results. That was the takeaway from a talk at MD&M West.

Health and Human Services (HHS) Secretary Alex Azar was peppered with questions about the Trump administration’s budget proposal for fiscal 2021 during a Feb. 13 Senate hearing. However, another theme that resonated during the hearing was Senate legislation addressing drug prices. Azar addressed the issue of price caps, while noting that the bill “leaves plenty of room” for both ample profit margins and innovation in drug development.