All News | FDA

Advertising & Promotion

Dec 15, 2017
Medtronic Settles With Five States for $12 Million Over Infuse Marketing
Dec 12, 2017
Bad Ad Studies Move Forward
Dec 11, 2017
FDA Issues Final Guidance on Product Names Used in Ads and Promotional Labeling
Dec 11, 2017
CSPI Asks FDA, FTC To Take Action on Opioid Withdrawal Aid Supplements
Dec 11, 2017
Opioid Lawsuits Combined in Ohio District Court
Dec 7, 2017
Appeals Court Panel Rules Against Whistleblower
Dec 7, 2017
Montana Sues Purdue Over Deceptive Opioid Marketing
Dec 4, 2017
OIG Rescinds Advisory Opinion on Patient Assistance Program
Dec 1, 2017
Supplement Company, Owner Settle with FTC, Maine
Dec 1, 2017
National Academies Report Calls for Repeal of DTC Advertising Tax Deduction

Good Clinical Practice

Apr 23, 2018
CBER Issues Tech Specs for Vaccine Submissions
Apr 19, 2018
Neb. Governor Approves ‘Right-to-Try’ Bill
Apr 19, 2018
Feds Propose Delaying Revised Common Rule Until January 2019
Apr 19, 2018
Grassley Probes Two Questionable Trials
Apr 18, 2018
ClinicalTrials.gov Adds Three FAQs
Apr 16, 2018
FDA Offers Streamlined Process for Determining If an IVD in an Oncology Trial is Significant Risk
Apr 3, 2018
FDA Issues PRO Guidance for COPD Trials
Mar 31, 2018
CROs Start Industry Standards Group
Mar 28, 2018
Comparison of U.S.-EU Registries Finds Different Completion Statuses for Trials
Mar 28, 2018
Mayo Clinic Uses Watson AI for Trial Matching

U.S. Food Labeling

FDA Regulation & Enforcement

Jan 7, 2021
FDA Warns Retailer About Undeclared Allergens
Jan 6, 2021
FDA Debars Three Former Insys Executives
Dec 29, 2020
Another Supplement Company and its Owner Plead Guilty to Charge of Marketing Unapproved SARMs
Dec 29, 2020
Senate Report Calls for Adding Payments to Tax-exempt Groups to Open Payments Database
Dec 24, 2020
Device Company CEO Charged with Securities Fraud for Falsely Claiming Development of COVID-19 Test
Dec 23, 2020
Court: Product Liability Claims Involving Contaminated Valsartan Not Preempted under FD&C Act, DSCSA
Dec 23, 2020
FDA Finalizes Labeling Guidance on Alternate Name for Potassium Chloride
Dec 21, 2020
Drug Company and Specialty Pharmacy Settle False Claims Act Case Over Payments to Foundations
Dec 16, 2020
N.C. Company, Owner Plead Guilty to Marketing Unapproved Steroid-like Drugs as Sports Supplements
Dec 16, 2020
Catheter Maker Issues Urgent Recall of Device Following Reports of 14 Deaths, Hundreds of Injuries

Medical Devices

Oct 1, 2015
Proposed Rule Would Drop ‘Knowledge Prong’ from Regulatory Definition of ‘Intended Use’ for Devices
Sep 25, 2015
Ubl Will Leave AdvaMed To Become President and CEO at PhRMA
Sep 24, 2015
Analogic Proposes $1.6 Million Settlement To Resolve SEC Investigation into Subsidiary
Sep 24, 2015
FDA Continues Push for Patient Preference Input on Devices with New Advisory Committee
Sep 16, 2015
FDA Public Workshops Scheduled for November Will Explore Aspects of Regulating NGS Diagnostic Tests
Sep 15, 2015
Obama Nominates Dr. Robert M. Califf as Next FDA Commissioner
Sep 1, 2015
Pilot Program Will Test Harmonized Device Submission Formats Developed by IMDRF on PMAs, 510(k)s
Aug 31, 2015
FDA Calls for Device Makers To Volunteer for Summary Quarterly Malfunction Reporting Pilot Program
Aug 31, 2015
FCC Clarifies Rules for RF-Based Devices
Aug 27, 2015
FDA Increases Fees Charged for Medical Device Export Certificates

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