All News | FDA

Advertising & Promotion

Mar 7, 2023
Permanent Injunctions Entered Against Three Distributors Over Marketing Claims
Feb 28, 2023
FDA Debars Former Chief Executive and Former Medical Director Over Marketing Claims
Feb 22, 2023
CDRH Issues Warning Letter Over Off-label Promotion
Feb 10, 2023
Studies Reveal That Most DTC Advertising Is for Drugs with Low Added Clinical Benefit
Feb 7, 2023
PMCPA Issues UK’s First Guidance on Social Media
Jan 29, 2023
NAD Finds Drug Claim Supported in Physician-Directed Messaging But Not in Consumer-Directed Ads
Jan 25, 2023
DePuy Synthes To Pay $9.75 Million To Resolve Allegations of Providing Free Devices to Surgeon
Jan 24, 2023
Physicians’ Group Files OPDP Complaint Over 60 Minutes’ Wegovy Segment
Jan 13, 2023
Omnibus Spending Act Codifies FDA Guidance on Communications with Payors
Jan 6, 2023
Arizona Sues Drug Maker Over Potency Statements

Good Clinical Practice

Jun 13, 2023
FDA Debars Two Former Trial Coordinators
Jun 11, 2023
FDA Issues Warning Letters to Two Clinical Investigators
Jun 5, 2023
Number of BIMO Inspection Observations Dips Slightly in FY 2022
May 28, 2023
Draft ICH GCP Guideline Looks To Aid Use of New Technology in Clinical Trials
May 14, 2023
FDA Opens Dialogue on Possible Benefits, Harms From Use of AI/ML in Drug Development
May 6, 2023
FDA: Decentralized Trials Still Need Central Location for Records
Apr 25, 2023
FDA Debars Former Trial Site Co-Owner
Apr 18, 2023
FDA Now Recommends Risk-Based Monitoring for Clinical Trials
Apr 13, 2023
FDA, OHRP Tell Sponsors How To Navigate Agency Pediatric Research Referrals
Mar 31, 2023
Clinical Investigators Receive Warning Letters Over Lack of IND and Not Following Protocol

U.S. Food Labeling

FDA Regulation & Enforcement

Jan 28, 2025
Congress Reintroduces Bills To Require Price Disclosures in DTC Ads
Jan 24, 2025
FDA Provides Draft Guidance on Labeling Plant-Based Alternative Foods
Jan 22, 2025
Providing Free Drug That Has Only Limited Coverage Will Not Trigger Sanctions, HHS OIG Says
Jan 17, 2025
FDA Proposes Front-of-Package Label for Food Products
Jan 15, 2025
OIG: Patient Assistance for Autologous T-Cell Treatment Would Not Trigger Administrative Sanctions
Jan 15, 2025
Former McKinsey Partner Pleads Guilty to Obstruction Charge Tied to Firm’s Advice to Purdue Pharma
Jan 10, 2025
FDA Issues ‘Safe Harbor’ Guidance on Providing SIUU Info to Health Care Providers
Jan 10, 2025
FDA Allergen Labeling Guidance Expands Interpretation of 'Milk,' 'Eggs'
Jan 8, 2025
Athira To Pay Over $4 Million To Resolve False Claims Allegations Stemming From Research Misconduct
Jan 5, 2025
FDA Sets Jan. 1, 2028, as Next Uniform Compliance Date for New Labeling Regs

Medical Devices

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