All News | FDA

Advertising & Promotion

May 4, 2016
U.S. Supreme Court Declines To Hear POM Wonderful’s Appeal of FTC Case
May 2, 2016
Australia Fines Manufacturer $1.7M for Misleading Packaging and Promotion
Apr 28, 2016
Ninth Circuit Affirms Dismissal of Deception Claims Based on Drugs’ Differing Prices, Package Colors
Apr 18, 2016
Warner Chilcott Sentenced To Pay $125 Million in Drug Promotion Case
Apr 18, 2016
Small Survey Finds Few Patients Ask Doctors About Drugs Seen in TV Ads
Apr 15, 2016
What Is “Truthful” in Off-label Promotion?
Apr 15, 2016
New Paradigm Seen for Criminal Off-label Cases After Vascular Solutions Decision
Apr 14, 2016
FTC Charges Five Companies With Falsely Marketing ‘Natural’ Products; Four Settle
Apr 7, 2016
British Panel Cites Mylan for ABPI Code Breaches Over Frozen Yogurt at Meeting
Apr 7, 2016
ACP ‘Concerned’ About DTC Drug Ads

Good Clinical Practice

Feb 3, 2017
Right-to-Try Bill Introduced in Maryland
Feb 3, 2017
Better System Needed to Review First-in-Human Trials
Feb 3, 2017
FDA Reiterates Importance of Phase 3 Trials
Feb 2, 2017
Right-to-Try Bills Introduced in Iowa
Jan 27, 2017
Common Rule Agencies Drop Plans for Excluded Research, Provide Eight Exemptions to the Rule
Jan 27, 2017
Revised Common Rule Makes Changes in Waiver and Alteration of Informed Consent Elements
Jan 26, 2017
Common Rule Revision Requires Posting of Consent Forms; Two ‘Additional’ Elements Added
Jan 26, 2017
Revised Common Rule Requires Concise Opening Summary of Key Informed Consent Information
Jan 24, 2017
Common Rule Revision Allows Broad Consent Option
Jan 23, 2017
Common Rule Revision Keeps Single IRB Review

FDA Regulation & Enforcement

Jul 3, 2019
Senate Finance Leaders Question Tax-exempt Groups Financial Relationships with Opioid Manufacturers
Jul 2, 2019
Pa. Doctor Indicted on Kickback Charges
Jul 1, 2019
OPDP Researchers Move Ahead with Disease Awareness Ad Research
Jul 1, 2019
Court Finds Use of Image of Competing Product Was Not False Advertising
Jul 1, 2019
Teva Reaches Agreement with Oklahoma Over Opioid Marketing
Jun 27, 2019
Insys Sales Representative Who Cooperated with Prosecutors Is Sentenced to Five Years of Probation
Jun 26, 2019
FDA Gives Go-ahead to Use of Qualified Health Claims for EPA, DHA
Jun 22, 2019
Third OPDP Untitled Letter of 2019 Cites Direct-to-Consumer Video
Jun 22, 2019
FDA Issues Final Guidance on Electronic Submission of Promotional Materials
Jun 22, 2019
OPDP Researchers Want To Study Oncology Indications in DTC TV Ads

Medical Devices

Nov 30, 2011
Bipartisan Legislation To Speed FDA Reviews Of Innovative Devices Introduced in the Senate
Nov 30, 2011
Extension of Deferred Prosecution Agreement Follows Major Personnel Changes at Wright Medical
Nov 30, 2011
FDA, CMS Launch Parallel Review Pilot Program
Nov 30, 2011
DFine Settles Kickback Allegations for $2.39 Million
Nov 30, 2011
Proposed Requirements for Mobile Medical Apps Need More Work, Health Care Coalition Tells FDA
Oct 31, 2011
Guidant Settles False Claims Charges for $9.25 Million
Oct 31, 2011
Draft Guidance on Streamlined De Novo Process Issued
Oct 31, 2011
510(k)-related Topics Included in 2012 Guidance Plan
Oct 31, 2011
FDA Issues Plan To Support Biomedical Innovation
Oct 31, 2011
AdvaMed Challenges Accuracy of IOM's 510(k) Report; Report Receives Mix Reviews During Public Meeting

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