All News | FDA

Advertising & Promotion

May 8, 2015
FDA Planning Public Hearing on Off-label Communication Sometime This Summer
May 8, 2015
APLB Issues Rare Untitled Letter Over Promotional Video for Flublok
May 7, 2015
FDA Yanks Four Promotional Draft Guidances, Including One on Help-seeking, Reminder Ads
Apr 30, 2015
OPDP Untitled Letter Cites Otsuka Over Claims in Promotional Pamphlet
Apr 23, 2015
FDA Draft Guidance Details Standards for Submitting Promotions Electronically
Apr 14, 2015
Two Former Acclarent Executives Indicted Over Alleged Off-label Promotion Conspiracy
Apr 7, 2015
Letter Pushes OPDP To Take Action Against Diabetes Ads Making Weight Loss Claims
Apr 6, 2015
FDA Seeks OMB Approval for Study of Price Comparisons in Ads
Mar 26, 2015
Appeals Court: Mandatory Disclosures Do Not Authorize Promotional Claims
Mar 19, 2015
GSK, McNeil Settle False Advertising Suit Concerning OTC Allergy Drug

Good Clinical Practice

Jul 28, 2016
FDA Softens Device Adaptive Design Guidance
Jul 25, 2016
HHS OIG Still Finds Problems with FDA’s Monitoring of Required Postmarket Studies
Jul 23, 2016
EMA Releases Concept Paper as First Step in Revising ‘First-in-Human’ Trial Guidelines
Jul 23, 2016
Informatics Experts Caution FDA on Use of EHR for Clinical Research
Jul 22, 2016
ACRP Offers Free Online Introductory Clinical Trials Training
Jul 21, 2016
Researchers Say Behavioral ‘Nudges’ Could Improve Trial Recruitment
Jul 16, 2016
Device Companies and Owner Will Pay $4.5 Million for NIH Grant Fraud
Jul 14, 2016
Expanded Access Is Important, But Getting Products Approved Is the Best Way To Get Drugs To People
Jul 13, 2016
ACP Supports National Academies’ Call To Halt Common Rule Revision
Jul 11, 2016
NIH Trial Innovation Network Gets Going

FDA Regulation & Enforcement

Mar 12, 2019
NCI Director Sharpless To Serve as Acting FDA Commissioner Following Gottlieb’s Departure
Mar 12, 2019
Pa. House Considers Bill Mandating Drug Cost Reporting
Mar 11, 2019
OPDP Moves Forward with HCP Survey
Mar 6, 2019
FDA Warns Canadian Rx Service Provider for Supplying Unapproved Drugs Through Employer Health Plans
Mar 6, 2019
FDA Issues Warning Letter for Marketing Laser as Sole Screening Device for Breast Cancer
Mar 5, 2019
Gottlieb Resigns as FDA Commissioner
Mar 5, 2019
Survey Finds Few Patients Looking Up Doctors on Open Payment Database
Mar 5, 2019
FDA Issues First Warning Letter Alleging Violations of the Drug Supply Chain Security Act Mandates
Mar 5, 2019
N.Z. Survey Finds Adults with Unhealthier Lifestyles More Responsive to DTC Ads
Mar 5, 2019
Survey Finds Public Support for Listing Prices in Drug Ads

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