The FDA has typically used real-world evidence (RWE) as a way of monitoring safety issues post-approval, especially through the Sentinel Initiative, which started in response to the FDA Amendments Act of 2007.
WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval.
WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval.
While other industries have completely modernized the way they manufacture their products, the biopharma industry, in large part, is stuck in the "this is how we've always done it" mode.
Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.
Incremental budget increases and continuing resolutions that hold FDA spending of both tax dollars and user fees to the previous year's level aren't going to cut it as the agency faces the growing challenge of reviewing more and more innovative technologies on the condensed timeframe of priority review.
SUZHOU, China – The global biotech market continues to look promising and Chinese companies are taking notice as they lay the foundation for new advances.
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low surgical risk, it’s tempting to think this device type has pretty much conquered all that lay before it. That’s not the case, however, as the question of bicuspid valve might be answered in a way that gives Edwards Lifesciences and Medtronic another sizeable patient population for their TAVR offerings. As is widely known, the FDA recently approved two TAVR devices each by Medtronic...
Device makers have reporting responsibilities for devices used in combination products per an FDA final rule published in 2016, but the FDA said in the 2018 draft guidance that the applicant of a drug- or biologic-led combo product must evaluate whether a malfunction of the device component would suggest a hazard for similar combinations using that device. That provision appears in the final rule, and thus puts the onus on makers of drugs and biologics to do a job device makers say is theirs to handle.
