#fda Archives - Orthopedics This Week

Legal & Regulatory and Reimbursement

Trump’s Tariffs, FDA and CMS Firings

by Robin Young February 26, 2025March 18, 2025

Legal & Regulatory and Reimbursement

New Study Tackles Poorly Designed FDA Studies

by Elizabeth Hofheinz, M.P.H., M.Ed. January 24, 2025April 10, 2025

Legal & Regulatory and Reimbursement

Chinese Testing Firms Receive FDA Warning Letters

by Kim DelMonico September 23, 2024November 1, 2024

Legal & Regulatory and Reimbursement

Does FDA Have a Handle on the Digital Future of Medicine?

by Robin Young September 27, 2023September 27, 2023

Legal & Regulatory and Reimbursement

FDA’s Draft Guidance for Patient-Matched Ortho Implant Guides

by Kim DelMonico September 14, 2023November 1, 2024

Legal & Regulatory and Reimbursement

CMS Stops Auto Payment Coverage for FDA Breakthrough Devices

by Walter Eisner November 19, 2021October 24, 2024

Legal & Regulatory and Reimbursement

Biden Picks Former Commissioner Califf to Retake FDA

by Walter Eisner November 19, 2021November 1, 2024

Legal & Regulatory and Reimbursement

FDA Issues Final UDI Guidance Document

by Walter Eisner August 2, 2021November 1, 2024

Legal & Regulatory and Reimbursement

FDA Rules to Expire in 2026

by Walter Eisner March 18, 2021November 1, 2024

Legal & Regulatory and Reimbursement

Novel Device FDA Authorizations Spike in 2020

by Walter Eisner March 8, 2021October 24, 2024

audio, Legal & Regulatory and Reimbursement

FDA Commissioner Hahn Rebuffs White House Over Vaccines

by Walter Eisner October 20, 2020October 24, 2024

Legal & Regulatory and Reimbursement

“Deep State” Charges Shake FDA Trust

by Walter Eisner September 3, 2020October 24, 2024

Legal & Regulatory and Reimbursement

Judge Orders Clinical Study Sponsors to Come Clean

by Walter Eisner August 19, 2020November 1, 2024

Legal & Regulatory and Reimbursement

Safety Alerts for Surgical Gowns and Drugs

by Walter Eisner January 31, 2020November 1, 2024

General Topics, Legal & Regulatory and Reimbursement, Reimbursement

Wallowing in the Mire of Drug Pricing

by Robin Young December 17, 2019December 19, 2019

Legal & Regulatory and Reimbursement

NuVasive CoRoent Cleared for Multiple Contiguous Cervical Levels

by Walter Eisner November 29, 2019November 1, 2024

Legal & Regulatory and Reimbursement

All Hands on Deck at FDA to Tackle Ethylene Oxide Shortages

by Walter Eisner November 26, 2019November 1, 2024

Legal & Regulatory and Reimbursement

Lack of EtO May Trigger Orthopedic Device Shortages

by Walter Eisner October 31, 2019October 24, 2024

Biologics

Biologics – Where’s the Damn Evidence?

by Robin Young October 9, 2019June 8, 2020

Legal & Regulatory and Reimbursement

How Will the FDA Regulate Medical Device Software?

by Walter Eisner October 3, 2019November 1, 2024

Legal & Regulatory and Reimbursement

Europe Dumps Its Regulatory System. Confusion Reigns

by Walter Eisner August 13, 2019October 24, 2024

Legal & Regulatory and Reimbursement

New Opioid Standards and Kratom Warning From FDA

by Bill Donovan July 16, 2019November 1, 2024

Legal & Regulatory and Reimbursement

How Will the FDA Regulate Artificial Intelligence?

by Walter Eisner July 1, 2019October 24, 2024

Legal & Regulatory and Reimbursement

FDA Clears Ultrasonic Device From Tenex Health

by Walter Eisner June 17, 2019November 1, 2024

Legal & Regulatory and Reimbursement

FDA Wants Your Views on Opioid Blister Pack Rule

by Bill Donovan June 4, 2019November 1, 2024

Legal & Regulatory and Reimbursement

Joint Replacement Infection Diagnostic Kit Approved by FDA

by Walter Eisner May 31, 2019November 1, 2024

Legal & Regulatory and Reimbursement

FDA Sends Warning Letter to Orchid Orthopedic

by Bill Donovan May 31, 2019November 1, 2024

Legal & Regulatory and Reimbursement

FDA Issues Class I Recall for Common Surgery Monitors

by Bill Donovan May 30, 2019November 1, 2024

Legal & Regulatory and Reimbursement

FDA’s Expansive Power to Search Facilities Reaffirmed with Limits

by Bill Donovan May 8, 2019November 1, 2024

Legal & Regulatory and Reimbursement

Single Lot of Injectable NSAID Recalled

by Bill Donovan May 3, 2019November 1, 2024

Tag: #fda

Trump’s Tariffs, FDA and CMS Firings

New Study Tackles Poorly Designed FDA Studies

Chinese Testing Firms Receive FDA Warning Letters

Does FDA Have a Handle on the Digital Future of Medicine?

FDA’s Draft Guidance for Patient-Matched Ortho Implant Guides

CMS Stops Auto Payment Coverage for FDA Breakthrough Devices

Biden Picks Former Commissioner Califf to Retake FDA

FDA Issues Final UDI Guidance Document

FDA Rules to Expire in 2026

Novel Device FDA Authorizations Spike in 2020

FDA Commissioner Hahn Rebuffs White House Over Vaccines

“Deep State” Charges Shake FDA Trust

Judge Orders Clinical Study Sponsors to Come Clean

Safety Alerts for Surgical Gowns and Drugs

Wallowing in the Mire of Drug Pricing

NuVasive CoRoent Cleared for Multiple Contiguous Cervical Levels

All Hands on Deck at FDA to Tackle Ethylene Oxide Shortages

Lack of EtO May Trigger Orthopedic Device Shortages

Biologics – Where’s the Damn Evidence?

How Will the FDA Regulate Medical Device Software?

Europe Dumps Its Regulatory System. Confusion Reigns

New Opioid Standards and Kratom Warning From FDA

How Will the FDA Regulate Artificial Intelligence?

FDA Clears Ultrasonic Device From Tenex Health

FDA Wants Your Views on Opioid Blister Pack Rule

Joint Replacement Infection Diagnostic Kit Approved by FDA

FDA Sends Warning Letter to Orchid Orthopedic

FDA Issues Class I Recall for Common Surgery Monitors

FDA’s Expansive Power to Search Facilities Reaffirmed with Limits

Single Lot of Injectable NSAID Recalled

The Promise of Biomimetic Implant Surfaces & Nano + Femtosecond Laser Texturing

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