All News | FDA

Advertising & Promotion

Feb 2, 2024
Advertising Agency Settles Litigation With States Over Opioid Marketing
Jan 23, 2024
OPDP Issues First Untitled Letter for 2024; Efficacy Claims Continue as Agency Focus
Dec 27, 2023
FDA Issues Guidance To Clarify Major Statement Final Rule
Dec 21, 2023
OPDP Researchers To Examine Implied Claims in DTC Drug Promotion
Dec 21, 2023
Court Upholds Convictions for Off-Label Promotion of Device, Rejecting First Amendment Arguments
Dec 13, 2023
Citizen Petition Calls for FDA To Remove ‘Misleading’ Promotional Claims From Botox Labeling
Nov 20, 2023
FDA Issues Final Rule on Major Statement in DTC Drug Ads
Nov 17, 2023
FTC Sends Warning Letters Regarding Lack of Disclosure in Social Media Posts
Nov 13, 2023
OPDP Issues Two Untitled Letters Alleging False or Misleading Claims in DTC Materials
Oct 31, 2023
FDA Issues Revised Draft Guidance on Providing Scientific Information on Unapproved Uses

Good Clinical Practice

Apr 22, 2024
WHO Details Benefits and Risks of Using AI in Drug Development
Apr 15, 2024
National Academies Recommend Use of PREA and BPCA as Models for Studies Involving Pregnant and Lactating Women
Apr 5, 2024
GAO: FDA Needs To Improve Recruitment and Retention of BIMO Investigators
Mar 30, 2024
NY Psychiatric Institute IRB and Investigator Are Issued Warning Letters
Mar 22, 2024
Senate White Paper Proposes HIPAA Overhaul
Mar 18, 2024
CDRH Sends Warning Letter for Myriad of Alleged Trial Problems
Mar 11, 2024
Joint FDA-OHRP Draft Guidance Details ‘Key Information’ in Informed Consent
Feb 28, 2024
Final COVID-19 Guidance Provides More Options for Trial Sponsors
Feb 16, 2024
New FDA Draft Guidance Focuses on When and How To Use Data Monitoring Committees
Feb 9, 2024
New FDA Draft Guidance on Race and Ethnicity Data Collection Recommends Including Race and Ethnicity Information in Proposed Labeling

U.S. Food Labeling

Dec 18,2023
FDA Updates Menu Labeling Guidance Regarding Added Sugars and TPP Nutrition Info
Dec 8,2023
Sugarcane Variant Added to Bioengineered Foods List
Dec 4,2023
FDA Gets Earful on Front-of-Package Labeling
Nov 29,2023
FDA Guidance Clarifies Yogurt Labeling Requirements
Nov 6,2023
CFSAN Updates Its Online Submission Module
Oct 23,2023
FDA Moving Ahead With FOPL Priority
Oct 10,2023
Can a Brand Name Deceive Consumers?
Sep 30,2023
Citizen Petition Requests That Gluten Be Declared a Major Food Allergen
Sep 25,2023
Bill To Study ‘Climate-Friendly’ Certification and Labeling Introduced in US House
Sep 20,2023
Citing Implied Preemption, First Circuit Affirms Dismissal of Complaint Targeting Lactaid Label Claims

FDA Regulation & Enforcement

May 14, 2025
Assertio Therapeutics Enters Into $3.6M Settlement To Resolve Off-Label False Claims Allegations
May 9, 2025
Gilead Agrees to $202 Million Settlement Over Speaker Program
May 9, 2025
FDA Extends Proposed FOP Rule Comment Period to July 15
May 7, 2025
FDA Announces Intent To Conduct More Unannounced Inspections at Foreign Manufacturing Facilities
May 5, 2025
House-Senate Bills Look To End DTC Ad Tax Deduction
Apr 30, 2025
State Law Claims Brought by Survivors of Victim of Faulty ICD Dismissed on Preemption Grounds
Apr 30, 2025
Doctor Faces Up to Three Years in Prison for Administering Non-FDA-Approved Semaglutide to Patients
Apr 25, 2025
FDA Moves To Remove All Petroleum-Based Dyes From Food
Apr 23, 2025
Florida Man Pleads Guilty to Wire Fraud in Connection With Distribution of Black-Market HIV Drugs
Apr 18, 2025
Menendez Reintroduces Caffeine Labeling Bill

Medical Devices

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