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BD has received 510(k) clearance for both remediation and return to full commercial operations of its updated Alaris infusion pump system, which was subject to an FDA class I recall in 2020, the most serious type of recall as use of the device may lead to serious injury or death. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
The Senate Health, Education, Labor and Pensions (HELP) Committee has advanced reauthorization of the 2006 Pandemic and All Hazards Preparedness Act (PAHPA), allowing the FDA to require that manufacturers notify the agency of potential product shortages when there’s no public health emergency (PHE). Read More
In an open public meeting, the FTC voted 3-0 Thursday to withdraw comments it has issued over the past 13 years in support of pharmacy benefit managers (PBM) – comments the PBM industry has begun using to defend itself in recent public relations campaigns. Read More
A regulatory affairs specialist for an eastern Pennsylvania medical device company has pled guilty to fabricating documents on FDA letterhead representing that two of his company’s products had received 510(k) clearances when, in fact, he had never made any submissions for the devices. Read More
Boehringer-Ingelheim, Eli Lilly and Novo Nordisk have added their support to a bipartisan, bicameral bill — the Treat and Reduce Obesity Act (S. 2407 and H.R. 4818) — to expand Medicare coverage of medications and health care specialists to treat obesity. Read More
Enabling more rapid Medicare coverage of medical technology innovations through support of CMS’s proposed Transitional Coverage for Emerging Technologies (TCET) was the goal of several devicemakers who spoke in support of the proposal at a recent House Energy and Commerce Health Subcommittee meeting. Read More
Bufferin, a brand synonymous with aspirin for many consumers, features in a head-scratcher FDA action as the agency withdraws the product’s 1948 NDA because the named manufacturer has failed to file required multiple annual reports on the prescription drug, which hasn’t been marketed for years. Read More
A tornado with winds of 150 mph slammed into Pfizer’s enormous drug manufacturing plant in Nash County, N.C., on July 19, knocking out the facility that makes 25 percent of the company’s injectable medications. Read More
Five drugs that are likely to make the Inflation Reduction Act (IRA) price negotiation list accounted for 13 percent ($29 billion) of 2021 Medicare Part D spending, but were less than one percent of all covered drugs according to a Kaiser Family Foundation (KFF) analysis of the latest available sales data from CMS. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More