The FDA is transitioning back to traditional regulatory processes to sign off on new COVID-19 tests after clearing more than 430 for emergency use during the pandemic, the agency said Sept. 27.
Category: Supply Chain
Supply issues keeping leaders up at night and 9 more supply chain updates
Here are 10 supply chain updates for ASC leaders to know that Becker’s has reported since Sept. 20:
Reliance on single-use devices leads to supply chain disruptions, HHS report says
A Department of Health and Human Services report found single-use medical devices account for most of hospital greenhouse gas emissions and lead to supply chain disruptions.
Amid Moderna’s booster shortage, FDA clears batches from unauthorized facility
After some pharmacies and hospitals reported running out of Moderna’s omicron-targeted booster, the FDA authorized five lots of the product made at the drugmaker’s Bloomington, Ind., facility, which isn’t authorized to manufacture the modified vaccine….
Pfizer executive: Drugmakers should ‘rethink’ supply chain logistics
With COVID-19 vaccine-makers pivoting production as the virus mutates, Jim Cafone, Pfizer’s senior vice president of global supply chain, said it is time for pharmaceutical companies to redevelop their logistic strategies, The Wall Street Journal repor…
FDA’s user fee program awaits renewal for next 5 years
Reauthorizing the FDA’s user fee program, which allows the agency to decide how much to charge pharmaceutical and medical device-maker companies for their product submissions, was added to a spending bill Sept. 22 to prevent a government shutdown…
FDA loosens restrictions on naloxone distribution
The FDA is loosening requirements surrounding the distribution of naloxone to increase Americans’ access to the opioid overdose antidote.
FDA’s authorization process hindered COVID-19 tests in 2020: HHS report
From an unusual number of submissions of low-quality COVID-19 tests to limits at U.S. laboratories, the FDA faced multiple barriers in the early days of the COVID-19 pandemic, an HHS report found.
Supply chain, staffing becoming ‘challenging beyond words,’ administrator says
For many ASCs, including Wilmington (N.C.) Surgcare, staffing and supply chain issues have plagued operations since the beginning of the COVID-19 pandemic.
Supply disruptions from Hurricane Fiona will be minimal, experts say
Drug and medical devicemakers with operations in Puerto Rico are cautiously optimistic that Hurricane Fiona will cause few ripples across the medical supply chain.
