All News | FDA

Advertising & Promotion

May 24, 2017
OPDP Issues First 2017 Untitled Letter Over Misleading Risk Info in DTC TV Ad
May 23, 2017
California Senate Approves Bill Clamping Down on Drug and Biologic Makers’ Gifts to Health Providers
May 22, 2017
Nevada Senate Passes Bill Requiring Sales Rep. Reporting
May 20, 2017
JAMA Viewpoint Calls for More Scrutiny of Disease Awareness Advertisements
May 20, 2017
Fourth N.Y. County Sues Pharmaceutical Companies Over Opioid Marketing
May 19, 2017
FDA Extends Intended Uses Rule Comment Period to July 18
May 18, 2017
FAIR Drug Transparency Bill Re-introduced
May 15, 2017
‘Native Ads’ Require Close Scrutiny
May 12, 2017
What’s In Store for the Gottlieb Era at FDA?
May 12, 2017
CME Organizers Continue To Struggle With COI

Good Clinical Practice

Nov 21, 2017
Gene Editing Trials Face Tough Ethical Questions
Nov 21, 2017
Melanoma Exchange Provides Trial Info
Nov 18, 2017
2018 Compilation of Human Research Standards Adds Four Nations, New Topic
Nov 14, 2017
NIH Starts Data Commons Pilot
Nov 14, 2017
Study Finds 45 Percent of EU Marketing Authorizations Based on Single Pivotal Trial
Nov 11, 2017
FDA Awards Grants to Aid Pediatric Trial Development
Nov 11, 2017
FDA Study Finds Trials Reporting Sex Data, But Minorities Are Still Under Represented
Nov 9, 2017
Sponsors Need To Evaluate Drug Effects on Driving
Nov 6, 2017
Lupus Foundation Study Finds New Model for Assessing Lupus Patient Outcomes
Nov 6, 2017
SACHRP Recommends Research Categories for Expedited IRB Review

U.S. Food Labeling

Nov 30,2011
WTO Panel Rules Against U.S.'s Mandatory COOL Law
Nov 30,2011
California Files 'Greenwashing' Lawsuit Against Firms Making Biodegradability Claims
Nov 30,2011
Ohio Agrees To Abandon Restrictive Labeling Regulation Involving 'rbGH Free' Claims
Nov 30,2011
Public Health Group Urges Sodium Regulation by FDA
Nov 30,2011
Federal Appeals Court Dismisses Fiber Suit Against Kellogg and General Mills
Nov 30,2011
Product Recalls
Nov 30,2011
Challenge to Food Product Labeling Preempted
Oct 31,2011
FTC Tells Lawmakers It Will Revise Proposed Guidelines for Marketing Foods to Kids
Oct 31,2011
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Oct 31,2011
Product Recalls

FDA Regulation & Enforcement

Medical Devices

Jul 16, 2014
Draft Guidance Outlines Benefit, Risk Factors in Substantial Equivalence Reviews of New Technology
Jul 10, 2014
Senators Call on OMB To Release Draft FDA Guidance on Laboratory-Developed Diagnostic Tests
Jun 30, 2014
FDA Outlines Overall Approach to Nanotechnology
Jun 27, 2014
Supreme Court Will Not Review Ninth Circuit Ruling That Failure-To-Warn Claim Is Not Preempted
Jun 25, 2014
Agency Releases Complete Final GUDID Guidance
Jun 25, 2014
Complete Final GUDID Guidance Document Is Released
Jun 23, 2014
Supreme Court Will Not Review Ninth Circuit Ruling That Failure-To-Warn Claim Is Not Preempted
Jun 20, 2014
FDA Plans Not To Enforce Regulatory Controls for Medical Device Data Systems, Citing ‘Critical’ Need
Jun 13, 2014
CDRH Sets ‘Plan of Action’ in Response to Independent Study of Device Submission Review Procedures
Jun 13, 2014
More Regulatory Challenges — and Some Real Opportunities — Emerge for Device Companies

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