All News | FDA

Advertising & Promotion

Nov 17, 2015
AMA Calls for Ban on DTC Ads
Nov 13, 2015
Court Issues Temporary Restraining Order Against Making Generic Nexium Purple
Nov 9, 2015
FDA Web Page Flags Fraudulent Marketing for Serious Diseases
Nov 5, 2015
POM Wonderful Asks Supreme Court To Consider FTC Case
Nov 4, 2015
Canadian Study Finds Rate of Adverse Events Higher for Off-label Use of Drugs
Nov 3, 2015
OMB Approves OPDP DTC Ad Study
Oct 29, 2015
Warner Chilcott Settles Charges Stemming from Kickbacks, HIPAA Violations for $125 Million
Oct 28, 2015
Novartis Sets Aside $400 Million to Settle Federal Specialty Pharmacy Case
Oct 14, 2015
Relator Must Wait for Appeal on Whether Fraud on the FDA Can Lead to False Claims Liability
Oct 12, 2015
CDRH Concerned Review Commitments Are Not Being Kept

Good Clinical Practice

Oct 29, 2016
SACHRP Develops Flow Chart, Recommendations for Federal Regulation of Cluster Randomized Trials
Oct 28, 2016
SACHRP Develops Points to Consider on Single IRB Review
Oct 28, 2016
IRB Written Procedure Guidance Needs More Clarity
Oct 27, 2016
SACHRP Gets Ready for Common Rule Revision By Clearing Its Backlog
Oct 24, 2016
NBME Starts Clinical Research Certification Program
Oct 24, 2016
Checklist of Study Core Outcome Sets Developed
Oct 20, 2016
EMA Starts Posting Clinical Reports
Oct 19, 2016
Few Firms Post Compassionate Use Policies
Oct 18, 2016
NMQF Develops Maps Detailing Cancer Prevalence by Key Factors
Oct 18, 2016
OpenTrials Database Launches Beta Version

FDA Regulation & Enforcement

May 1, 2019
FDA Seeks Input on Cannabis as Food, Supplement Ingredient
May 1, 2019
AMS Makes Changes to National List
May 1, 2019
FSIS Proposes To Amend Dual Content Regulations
Apr 29, 2019
Grassley, Wyden Question Physician-Owned Distributorships’ Compliance with Sunshine Act Reporting Mandates
Apr 29, 2019
Two Drug Companies To Pay $125 Million To Resolve Kickback Allegations Involving Co-pay Assistance
Apr 26, 2019
Connecticut Files Amended Lawsuit Against Purdue Pharma
Apr 25, 2019
FDA Modifies Mandatory Labeling Declaration for Allulose
Apr 24, 2019
Draft FDA Guidance Shows How Companies Should Prepare for, Initiate Voluntary Product Recalls
Apr 23, 2019
J&J To Pay $9.9 Million To Settle Washington Suit Over Disclosure of Surgical Mesh Risks
Apr 22, 2019
OPDP-RTI Review of DTC Studies Finds Both Potential Benefits and Harms

Medical Devices

Jan 31, 2011
FDA Identifies 19 Steps To Improve Center Transparency
Jan 31, 2011
Parallel Reviews Must Be Voluntary, AdvaMed Says
Jan 31, 2011
IDE Review Longer Than Reported, Survey Finds
Jan 31, 2011
Exactech Enters Into DPA Over Kickback Allegations
Dec 31, 2010
Synthes, Norian Plead Guilty for Alleged Involvement in Conducting Unauthorized Trials
Dec 31, 2010
FDA, Health Canada Say Joint Agency Audits Work
Dec 31, 2010
CDRH To Issue Plan for 510(k) Program Changes
Dec 31, 2010
California Appeals Court Says Federal Law Preempts State Claims Arising From Device Clinical Trials
Dec 31, 2010
IOM Panel: Incentives Needed for HDE Development
Dec 31, 2010
FDA Concerned About External Defibrillator Safety

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