All News | FDA

Advertising & Promotion

Nov 5, 2016
OPDP Sends Fifth Untitled Letter of 2016 Questioning Spanish Opinion Leader Video
Nov 4, 2016
NEJM Perspective Calls for Federal Court Rejection of Caronia Decision
Nov 2, 2016
Three Warner Chilcott Sales Managers Sentenced in Connection with Prior Authorization Scheme
Nov 1, 2016
FDA Responds to Comments About Its Planned DTC Animation Studies
Oct 26, 2016
U.K. Advertising Standards Authority Nixes Health Ad
Oct 24, 2016
Allegedly Fraudulent Marketer of $12 Million in Pharmaceuticals Pleads Guilty to Wire Fraud
Oct 24, 2016
CDRH Web Page Provides Information, Interactive Form for Reporting Alleged Regulatory Misconduct
Oct 24, 2016
Medtech Companies Not Reviewing All Elements of Sales Compensation Plans
Oct 24, 2016
What To Expect from the FDA Off-label Hearing Nov. 9-10
Oct 19, 2016
CFSAN, FTC Issue Joint Warning Letter over Dietary Supplement Company’s Unsubstantiated Advertising

Good Clinical Practice

Jun 5, 2017
CTTI Launches Project on Investigator Qualification
Jun 2, 2017
Komen Launches Toll-free Breast Cancer Clinical Trials Helpline
Jun 1, 2017
SACHRP Recommends Delaying Revised Common Rule Effective Date
May 31, 2017
AAHRPP Requests Common Rule Revision Delay
May 30, 2017
Nevada Governor Approves Bill Encouraging Trial Participation
May 28, 2017
SACHRP Finds Incidental Findings Do Not Have To Be Handled the Same as Individual Research Results
May 28, 2017
SACHRP Asks FDA to Better Define Clinical Investigation
May 24, 2017
EMA Releases Guideline on Serious Breach Reporting
May 24, 2017
ACRO Calls Right-to-Try Laws ‘Deeply Flawed’
May 20, 2017
Bill Encouraging Trial Participation Approved by Nevada Legislature

U.S. Food Labeling

Sep 30,2010
FDA Mulls Approval and Labeling of Biotech Salmon
Sep 30,2010
POM Takes FTC to Court over New Substantiation Standard and Prior Approval of Claims
Sep 30,2010
FDA Puts Industry on Notice with Two Warning Letters Targeting Antioxidant Claims
Sep 30,2010
Product Recalls
Sep 30,2010
Fiber Labeling Lawsuit Against General Mills and Kellogg Dismissed by Federal Judge
Aug 31,2010
CSPI Urges Unilever To Remove 'All Natural' Claims From Ben & Jerry's Ice Cream Labels
Aug 31,2010
Miami Juice Maker Gets Warning Letter for Long List of Misleading Claims on Web and Labels
Aug 31,2010
Kellogg and General Mills United in Opposition To Color-Coded 'Traffic Light' FOP System
Aug 31,2010
Courts Seek FDA Guidance on 'Natural' Claims For Beverages Containing HFCS
Aug 31,2010
Product Recalls

FDA Regulation & Enforcement

Oct 28, 2019
Revised Draft Guidance, Withdrawal of CPG Signal Tougher FDA Enforcement for Homeopathic Drugs
Oct 25, 2019
House Bill Introduced To Remove Tax Deduction for Drug Ads, Other Promotional Activities
Oct 25, 2019
Ky. Receives $17 Million Settlement Over Claims for Birth Control Drugs
Oct 24, 2019
States Reach $700 Million Settlement With Reckitt Over Suboxone Marketing
Oct 24, 2019
AMS Describes More Changes Ahead for Organic Program’s National List
Oct 21, 2019
Court: Device Firm Must Give Relator Materials That Were Provided to Government Before DOJ Declined To Intervene
Oct 21, 2019
Survey of Open Payment Data Finds Amount of Payments, Number of Physicians Holding Steady
Oct 21, 2019
Mississippi Hospitals Sue Opioid Makers
Oct 21, 2019
J&J, Ethicon To Pay $116 Million To Resolve Lawsuit Over Transvaginal Surgical Mesh Promotion
Oct 18, 2019
Ninth Circuit: Device Defect Alone Does Not Show Violation of FDA Mandates, So Claims Are Preempted

Medical Devices

Mar 21, 2013
FDA Can Access, Spend Higher MDUFA III User Fees Under FY 2013 Spending Measure Passed by Congress
Mar 13, 2013
Draft Guidance for Third Party Review Accreditation Released
Mar 13, 2013
Study Finds Improvements in Number, Speed of 510(k) Clearances
Mar 12, 2013
FDA, FTC Threaten Cosmetic Contact Lens Marketers With Prosecution in Joint Enforcement E-mail
Mar 7, 2013
Draft Guidance on Distinguishing Device Recalls From Enhancements Draws Questions, Criticism
Mar 5, 2013
Draft Guidance Outlines Communications With FDA During Device Reviews
Feb 15, 2013
FDA Finalizes HUD Designation Guidance
Feb 15, 2013
FDA To Hold Workshop on ‘Accessible’ Labeling
Feb 14, 2013
CDRH Warning Letter Targets Israeli Device Firm’s Marketing
Feb 6, 2013
CMS Expands DMEPOS Competitive Bidding Program

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