All News | FDA

Advertising & Promotion

Aug 10, 2015
OPDP Warning Letter Blasts ECR Over Risk Info Missing From Sales Aid
Aug 8, 2015
Injunction in Amarin Case Permits Off-label Claims, Bars FDA Action
Aug 4, 2015
Feds Reject Amarin Claims in Line-by-Line Rebuttal
Jul 30, 2015
Dispute Over ‘Natural’ Claims Leads NAD To Refer Case to FTC
Jul 17, 2015
Planned OPDP Research To Examine Effect of Market Claims on Consumer Perceptions
Jul 14, 2015
Untitled Letter Complains that Promotional Card Omitted Boxed Warning Information
Jul 14, 2015
Justice Department Fights Injunction Request In Amarin Lawsuit, Relies on FDA Letter
Jul 8, 2015
Google To Eliminate Tailored URLs, Special Ad Formats for Drug Advertisers
Jun 25, 2015
FDA To Study Effect of Hearing Loss on Comprehension of Major Statement
Jun 18, 2015
Merck Subsidiary To Pay $5.96 Million To Settle Off-label Promotion Allegations

Good Clinical Practice

Sep 8, 2016
AAHC Offers Trial Administration Toolkit
Sep 8, 2016
Cancer Moonshot Recommendations Include Clinical Trial Issues
Sep 2, 2016
Court Rules Administrative Research Misconduct Actions Must Be Complete Before Judicial Review
Aug 31, 2016
FTC Charges Academic Journal Publisher Deceived Researchers, Conference Attendees
Aug 31, 2016
Clinical Trials Play a Role in Illinois Appeals Court Allowing Out-of-State Plaintiffs’ Case
Aug 24, 2016
Another ‘Right-to-Try’ Bill Sent to California Governor
Aug 24, 2016
JAMA Surgery Commentary Calls for Mandating Matching Sex Inclusion in Studies
Aug 15, 2016
Get Patients Involved in Study Development Early
Aug 15, 2016
Toxicity Found in Fatal French Drug Trial Not Present in Similar U.S. Trials
Aug 12, 2016
FDA Issues Draft Guidance on Trial Endpoints for Ulcerative Colitis Studies

FDA Regulation & Enforcement

Apr 3, 2019
District Court Allows Kickback Case Against Novartis To Continue
Mar 30, 2019
New York Sues Six Drug Makers, Four Distributors and Sackler Family Over Opioid Marketing
Mar 30, 2019
Illinois Bill Would Ban Physician ‘Gifts’
Mar 28, 2019
Legislation Introduced to Stop Nondairy ‘Milk’ Labeling
Mar 27, 2019
FDA Will Not Enforce FSMA Produce Safety Rule with Respect to Some Foods Due to ‘Unique Circumstances’
Mar 27, 2019
Oklahoma-Purdue Reach $270 Million Settlement in State Opioid Case
Mar 27, 2019
Local Entities Sue Sacklers Over Opioid Marketing
Mar 23, 2019
District Court Dismisses Securities Fraud Case Involving Off-Label Marketing Concerns
Mar 23, 2019
Montana Bill Examines Drug Price Transparency
Mar 23, 2019
House Oversight Committee Requests Info on OxyContin Marketing

Medical Devices

Jul 31, 2010
Compliance Director Discusses Enforcement Trends
Jul 31, 2010
Bill Introduced To Repeal Device Industry Tax
Jul 31, 2010
HHS Proposed Rule on Investigator Conflict of Interest Puts Onus on Institutions To Monitor, Report Conflicts
Jul 31, 2010
St. Jude's Epicor Promos Violate FD&C Act, CDRH Says
Jul 31, 2010
CMS Expecting Big Savings From Competitive Bidding
Jun 30, 2010
FDA Transparency May Raise Concerns for Manufacturers
Jun 30, 2010
CDRH Announces ISO 13485-based Single Audit Program
Jun 30, 2010
Proposed New Federal Sentencing Guidelines Could Affect Corporate Compliance, Ethics Programs
Jun 30, 2010
Experts Offer Advice on Launching Products Abroad

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