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publication date

Covid-19
FDA Experts Are Still Puzzled Over Who Should Get Which COVID Shots and When
Kaiser Health News | January 27, 2023
Panel disagrees with FDA proposal that everyone get at least one shot a year, saying more information is needed.
Clinical Care
The Tests Are Vital. But Congress Decided that Regulation Is Not.
ProPublica | January 25, 2023
Money and lobbying help shield lab-developed tests, including prenatal screenings, from heightened federal scrutiny.
Supply Chain
FDA eases outsourcing facility ibuprofen compounding for hospitals
American Hospital Association | January 23, 2023
To help hospitals and health systems meet demand during the current surge in respiratory illnesses for fever-reducing products to treat...
Pharma
FDA Rejects Fast-Track Approval of Eli Lilly's New Alzheimer's Drug
John Commins | January 20, 2023
Regulators want more evidence that the pricey drug works.
Pharma
CMS Pressed to Cover Leqembi After FDA Fast-Tracks Approval of Alzheimer's Drug
John Commins | January 09, 2023
Without insurance coverage, out-of-pocket costs for the drug will average about $26,500 per patient per year.
Innovation
Senators Introduce Bill to Support Coverage of Digital Therapeutics
Eric Wicklund | December 15, 2022
The Medicaid and CHIP Access to Prescription Digital Therapeutics Act, introduced this week in Congress, would create standardized coverage in...
Supply Chain
Drug Supply Chain Security Act 2023 Deadline: 'All Parties Must Do Their Part'
Christopher Cheney | October 06, 2022
A decade-long process to secure the safety and security of the pharmaceutical supply chain is nearing the finish line.
Revenue Cycle
FDA announces serious medical device recall
American Hospital Association | August 15, 2022
The Food and Drug Administration today announced a Class 1 recall of devices used to access blood vessels through a...
Post-Acute
Baxter Health Issues Recall for Volara Systems Due to Risk to Home Care Patients
Jasmyne Ray | June 27, 2022
More than 250 devices have been recalled so far.
Pharma
Pharma Faces Sweeping Legislative Changes
Ana Mulero | April 27, 2022
The bills aim to speed the discovery of new cures, improve patient representation in clinical trials, and enhance the FDA's...
Pharma
FDA Authorizes Second COVID-19 Vaccine Booster
Ana Mulero | April 27, 2022
The space has become increasingly controversial, with varying new recommendations.
Pharma
FDA Calls on Drugmakers to Be 'Recall Ready'
Ana Mulero | March 30, 2022
Final guidance is available that clarifies the agency's expectations about voluntary product recalls.
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