All News | FDA

Advertising & Promotion

Mar 9, 2016
FDA and Amarin Settle Off-label Lawsuit
Mar 7, 2016
FDA Will Study Effect of Animation in DTC Drug Ads
Mar 5, 2016
Franken Introduces Bill To Remove DTC Expense Deduction
Feb 29, 2016
FDA Plans National Survey on Direct-to-Consumer Ads
Feb 27, 2016
Dietary Supplement False Advertising Case Moves Forward in U.S. District Court
Feb 24, 2016
Dr. Robert M. Califf Confirmed by Senate as New Commissioner of Food and Drugs
Feb 22, 2016
Group Proposes Changes for Off-label Communication
Feb 17, 2016
DeLauro Introduces Bill Restricting DTC Ads
Feb 16, 2016
Illinois House Bill Urges Congress To Ban Direct-to-Consumer Drug Ads
Feb 16, 2016
MHRA Issues Warnings on Promotions

Good Clinical Practice

Jan 7, 2017
Common Rule Revision Sent to OMB for Final Review
Jan 5, 2017
FDA Offers Webinar Jan. 24 on Collecting Race and Ethnicity Data in Clinical Trials
Jan 5, 2017
Ohio Governor Signs ‘Right-to-Try’ Bill
Dec 26, 2016
UK GCP Guidance Updated To Include Section on Infringement Notices
Dec 22, 2016
Group Contends British Clinical Trials ‘Seriously Undermined’ by EU Regulations
Dec 22, 2016
European Parliament Pushes European Commission on Pediatric Trials
Dec 21, 2016
Checklist Released for Determining Whether a Study Must Be Registered in ClinicalTrials.gov
Dec 20, 2016
HHS Names New SACHRP Chair, Four Members
Dec 17, 2016
NIH Pushes Back Implementation of Single IRB Policy to September 2017
Dec 15, 2016
ACRES, BSI Launch Work Group To Develop Standards for Clinical Research Sites

FDA Regulation & Enforcement

Jun 10, 2019
OPDP Research Finds High-Distraction Ads Reduce Consumer Recognition of Risk Info
Jun 10, 2019
CBER Sends Stem Cell Firm Untitled Letter
Jun 8, 2019
U.S. Files Lawsuit Against Mallinckrodt Over Use of Charity Foundation
Jun 7, 2019
Former CEO To Pay $2.5 Million To Settle False Claims Act Case in Florida
Jun 7, 2019
Three States Sue Sackler Family
Jun 6, 2019
Insys Agrees to $225 Million Global Resolution of Allegations of Illegal Promotion of Subsys
Jun 6, 2019
Insys CIA Includes Novel Provisions
Jun 6, 2019
Second Circuit: Patient’s Tort Claims Related to Allegedly Defective Implants Untimely Under New York Law
Jun 6, 2019
District Court Grants FDA Injunction Against Florida Companies Providing Stem Cell Therapies
Jun 6, 2019
FDA Recommends Use of ‘Best if Used by’ on Date Label

Medical Devices

Aug 31, 2011
AdvaMed Pushes for 'Timely Action' on Repeal of Device Tax in Letter to Congressional Leaders
Jul 31, 2011
Senate Leaders Investigate Alleged Financial Ties Between Medtronic and Spinal Surgeons
Jul 31, 2011
FDA To Examine 'Objective Intent' of IVD Labeling To Determine Manufacturers' Role in Off-label Uses
Jul 31, 2011
Appeals Court Ruling Expands Scope of Liability For Manufacturers Under False Claims Act
Jul 31, 2011
Senators Call for Postmarket Surveillance Overhaul
Jul 31, 2011
AdvaMed Unveils Global Competitiveness Plan
Jul 31, 2011
J&J To Halt Production of Cypher Line of Stents
Jul 31, 2011
Senate Asks OIG To Investigate and CMS To Address Conflicts Raised by Physician-owned Distributors
Jul 31, 2011
FDA To Exempt Certain IVDs, Radiological Devices
Jul 31, 2011
CDRH Issues SOP for Notice to Industry Letters

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