All News | FDA

Advertising & Promotion

Oct 4, 2016
GSK To Pay $20 Million in Wake of SEC Charges of ‘Corrupt Payments’ to Providers in China
Oct 3, 2016
Court Dismisses Parallel State Tort Claims Over Off-label Promotion
Sep 29, 2016
MIWG Files Brief Supporting Facteau and Fabian
Sep 29, 2016
N.Y. Consumer False Ad Case Moves Forward
Sep 28, 2016
Group Calls for Maryland To Require Drug Price Disclosure Including Marketing
Sep 22, 2016
NY Sales Rep Convicted of Transporting Stolen Medical Devices, Conspiracy, Money Laundering
Sep 19, 2016
OPDP Examines Pre-Approval Claims
Sep 19, 2016
OPDP Warns Companies Promoting Investigational Drug
Sep 19, 2016
Physician’s Felony Adulteration Conviction for Reusing Single-Use Devices Upheld on Appeal
Sep 8, 2016
HHS Tells Congress Legislation Is Not Needed for ‘Off-label’ Communications

Good Clinical Practice

May 2, 2017
ACRP Issues Study Monitoring Framework
May 2, 2017
Improving Protocols and Communications Will Aid Trial Quality, ACRP Survey Finds
May 1, 2017
Researchers Question Results from Russian Portion of TOPCAT Trial
Apr 29, 2017
RCT Is Preferred Design for Trials During Epidemics
Apr 29, 2017
Clinical Trial Plans Need To Be Ready for Epidemics
Apr 27, 2017
Site Survey Finds Ways To Improve Study Payments
Apr 27, 2017
Study Finds Concise Consent Document Neither Hinders Nor Improves Participant Comprehension
Apr 26, 2017
JAMA Viewpoint Contends Three Concerns Need To Be Resolved Before Single IRB Review Is Mandated
Apr 26, 2017
ACRP Partners with DrugDev to Provide Researcher and Site Online Profiles
Apr 25, 2017
Research Integrity Best Practices Listed

U.S. Food Labeling

Jun 30,2010
FTC Expands Order Against Kellogg and Raises Bar on Scientific Evidence for Claims
Jun 30,2010
FDA Exercising Wider Oversight over Online Claims
Jun 30,2010
Industry Group Scores First Amendment Win on Qualified Health Claims

FDA Regulation & Enforcement

Oct 2, 2019
J&J Settles in Opioid Marketing Bellwether Case
Sep 30, 2019
Avanir Settles Claims Involving Nuedexta Marketing
Sep 30, 2019
OPDP Issues Two Enforcement Letters in September Citing Risk Information
Sep 26, 2019
Former Pharmakon CEO Sentenced to 33 Months in Prison Following Conviction for Conspiracy, Adulteration
Sep 26, 2019
Congressional Letter Asks Sharpless to Make Haste on Allowing CBD in Food
Sep 18, 2019
Manufacturer, Subsidiary To Pay $9.5 Million To Resolve Liability for Marketing Devices Not Cleared by FDA
Sep 18, 2019
Petition Seeks Changes to FSIS Labeling Regulations for Processed Meat
Sep 16, 2019
Court Allows RICO Claims To Continue in Multidistrict Opioid Litigation
Sep 14, 2019
More Hospitals Sue Opioid Makers
Sep 13, 2019
Pennsylvania Files Lawsuit Against Sackler Family

Medical Devices

Dec 7, 2012
Industry Reaction to Release of Final Tax Regulations
Dec 7, 2012
Final Device Tax Regulations Released by IRS
Dec 3, 2012
FDASIA Accelerates UDI Requirements for Some Devices
Dec 1, 2012
Guidance Documents Outline Effects of Various Actions on Performance Goals
Nov 13, 2012
Senate Report Alleges Medtronic’s Influence Over ‘Manipulated’ Studies, Failure to Reveal Payments
Nov 7, 2012
Draft Guidance Outlines Device Submission eCopy Standards
Nov 1, 2012
FAQs on New Device Registration, Listing Requirements Released
Nov 1, 2012
New CDRH SOP Governs Differences of Opinion Within Center
Nov 1, 2012
Scrutiny of 510(k) Program, Complaint Follow-up by FDA Included in HHS OIG’s Work Plan for FY 2013
Nov 1, 2012
Postmarket Challenges, Potential Strengthening for the Reporting of Information Security Problems

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