All News | FDA

Advertising & Promotion

May 10, 2018
30 Calif. Counties Announce Opioid Lawsuits
May 10, 2018
NAD Recommends Challenged Claims for Cold Sore Treatment Be Discontinued
May 9, 2018
MHRA Issues Two Promotion Rulings
May 8, 2018
Tenn. Governor Signs Bill Allowing Truthful Promotion of Off-label Uses
May 3, 2018
Physician Found Guilty of HIPAA Violation in Marketing Case
May 2, 2018
District Court Allows Kickback Case to Proceed
Apr 29, 2018
Teamsters Sue Opioid Manufacturers
Apr 27, 2018
NAD Refers Claims to FDA, FTC
Apr 26, 2018
Minnesota Congressman Mulls Bill To Ban Opioid Ads
Apr 23, 2018
USITC Launches Investigation of Clidinium Bromide Products

Good Clinical Practice

Aug 16, 2018
Studies Find Only One-Third of Researchers Declare COI in Journal Articles
Aug 13, 2018
Groups Propose FDA Guidance on Cancer Trial Eligibility Criteria
Aug 13, 2018
FDA Draft Guidance Details FIH Multiple Cohort Trials
Aug 13, 2018
FDA Sets October Workshop for Development of Patient-Focused Guidance
Aug 10, 2018
U.S. Rep., Two Others Charged with Insider Trading Over Disclosure of Negative Trial Results
Aug 10, 2018
Workshop Considers Subpopulations
Aug 8, 2018
EC Releases Draft GCP Guidelines for Advanced Therapies
Aug 6, 2018
FDA Suggests Additional Endpoint for OUD Trials
Aug 3, 2018
EMA Clarifies Role and Need for DMCs
Jul 31, 2018
CTTI Releases Road Map for Using Mobile Technologies in Clinical Trials

U.S. Food Labeling

FDA Regulation & Enforcement

Jul 8, 2021
USDA Commits to Wholesale Review of ‘Product of USA’ Labeling
Jul 2, 2021
J&J Reaches Settlement with New York Over Opioids
Jun 30, 2021
HHS OIG: Device Maker’s Discount Program for Hospitals Would Not Raise Health Care Fraud Concerns
Jun 26, 2021
OPDP Continues Study of Unapproved Use Data
Jun 24, 2021
DOJ Obtains Guilty Pleas from Individuals, Supplement Companies on Charges of Distributing Steroids
Jun 23, 2021
FDA Updates Standard of Identity for Yogurt Products
Jun 21, 2021
GAO Finds DTC Ads May Be Factor in Medicare Costs
Jun 16, 2021
Generic Drug Maker, Two Executives Indicted for Allegedly Deceiving FDA About Sourcing of API
Jun 15, 2021
NOSB Will Meet in October
Jun 13, 2021
OPDP Researchers To Examine Accelerated Approval Disclosures on DTC Websites

Medical Devices

Aug 8, 2016
FDA Releases Draft Guidance on When Device Modifications Trigger 510(k) Requirement
Aug 3, 2016
DOJ Charges Device Development Company, Owner with Fraud in Connection with Three NIH Grants
Aug 1, 2016
FDA’s Medical Device User Fees To Drop in Fiscal Year 2017
Jul 29, 2016
Device Center Highlights EFS Considerations
Jul 28, 2016
FDA-CMS Looking to Simplify Device Coverage
Jul 28, 2016
FDA Softens Device Adaptive Design Guidance
Jul 27, 2016
Acclarent Resolves False Claims Charges Related to Alleged Off-label Marketing for $18 Million
Jul 26, 2016
Draft Guidance Covers Form, Content Issues Involved with Unique Device Identifiers
Jul 21, 2016
FDA Issues Draft Guidance on Codevelopment of Therapeutic Products, Companion Diagnostics
Jul 11, 2016
Draft Guidance Documents on NGS-Based Tests Seek ‘Dynamic and Flexible’ Regulatory Pathway

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