The FDA announced as part of its annual budget proposal that it will seek $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a […]
supply chain
Biden administration wants to boost funding for new pharma manufacturing processes
The Biden administration today released findings from 100-day supply chain assessments, determining the need to boost pharmaceutical manufacturing. According to a fact sheet, the administration plans to take immediate action to “address vulnerabilities and strengthen resilience” with its effort to take on near-term supply chain disruptions for four products: semiconductor manufacturing and advanced packaging; large […]
FDA seeks more money, authority in budget request
The FDA wants more money from Congress for the coming fiscal year — and more power, too. Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory […]
AdvaMed wants input on Biden pandemic DPA use
AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words. In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump. Get the full story […]
10 trends that will matter for life sciences in 2021
One silver lining of the COVID-19 pandemic is that it has accelerated the rate of change for pharma and life sciences fields in general. The pandemic has forced a rethink of how to manage clinical trials and treat patients in hospitals and their homes. And the breakneck speed of vaccine development in 2020 could potentially […]
Congressional leaders want more info on COVID supply chain
Leaders in both houses of Congress want federal trade officials to further investigate the supply chain for COVID-19-related goods and devices, but don’t expect any answers before December. Members of the House Ways and Means and Senate Finance committees wrote a letter to U.S. International Trade Commission (USITC) chairman Jason Kearns last week, asking for a more […]
COVID-19 lessons learned: 2 manufacturers, a healthcare system and a logistics company share their wisdom
The COVID-19 pandemic put medtech contract manufacturers, OEMs, distributors and healthcare providers in situations for which they were unprepared, particularly with their supply chains. What they learned will undoubtedly help them all going forward, especially if the world faces a second wave or another novel virus. Here are some supply chain lessons learned by a […]
VA hospitals’ PPE supplies inadequate for second wave of COVID-19
U.S. veterans hospitals have only about a 30-day supply of personal protective equipment at the ready for staff use should a second wave of COVID-19 strike the nation, a VA official told a Senate committee this week. Dr. Richard Stone, executive in charge of the U.S. Department of Veterans Affairs, testified that the agency operates […]
U.S. senators demand investigation of Trump COVID-19 supply chain effort
Three U.S. senators today demanded an investigation into Project Air Bridge, a Trump administration supply chain management project to import personal protective equipment (PPE) and other medical supplies during the COVID-19 pandemic. Dubbing the project “opaque,” U.S. Senators Elizabeth Warren (D-Mass.), Chuck Schumer (D-N.Y.) and Richard Blumenthal (D-Conn.) also released new documents and information from […]
Senate Dems propose federalizing medical supply chain
Senate Democrats today introduced a bill that would put control of the nation’s medical supply chain in the hands of the federal government, using its expertise in military production and distribution to address the COVID-19 pandemic. The Medical Supply Delivery and Transparency Act would require the secretary of defense to appoint a civilian with experience […]
