Covid-19FDA Experts Are Still Puzzled Over Who Should Get Which COVID Shots and When
Panel disagrees with FDA proposal that everyone get at least one shot a year, saying more information is needed.
Clinical CareThe Tests Are Vital. But Congress Decided that Regulation Is Not.
Money and lobbying help shield lab-developed tests, including prenatal screenings, from heightened federal scrutiny.
Supply ChainFDA eases outsourcing facility ibuprofen compounding for hospitals
To help hospitals and health systems meet demand during the current surge in respiratory illnesses for fever-reducing products to treat...
PharmaFDA Rejects Fast-Track Approval of Eli Lilly's New Alzheimer's Drug
Regulators want more evidence that the pricey drug works.
PharmaCMS Pressed to Cover Leqembi After FDA Fast-Tracks Approval of Alzheimer's Drug
Without insurance coverage, out-of-pocket costs for the drug will average about $26,500 per patient per year.
InnovationSenators Introduce Bill to Support Coverage of Digital Therapeutics
The Medicaid and CHIP Access to Prescription Digital Therapeutics Act, introduced this week in Congress, would create standardized coverage in...
Supply ChainDrug Supply Chain Security Act 2023 Deadline: 'All Parties Must Do Their Part'
A decade-long process to secure the safety and security of the pharmaceutical supply chain is nearing the finish line.
Revenue CycleFDA announces serious medical device recall
The Food and Drug Administration today announced a Class 1 recall of devices used to access blood vessels through a...
Post-AcuteBaxter Health Issues Recall for Volara Systems Due to Risk to Home Care Patients
More than 250 devices have been recalled so far.
PharmaPharma Faces Sweeping Legislative Changes
The bills aim to speed the discovery of new cures, improve patient representation in clinical trials, and enhance the FDA's...
PharmaFDA Authorizes Second COVID-19 Vaccine Booster
The space has become increasingly controversial, with varying new recommendations.
PharmaFDA Calls on Drugmakers to Be 'Recall Ready'
Final guidance is available that clarifies the agency's expectations about voluntary product recalls.