All News | FDA

Advertising & Promotion

Aug 12, 2016
Promotional Meeting Draws Ire of PMCPA and MHRA
Aug 10, 2016
Biomet Says Additional Liabilities ‘Probable’ Due to Alleged Marketing Practices in Brazil, Mexico
Aug 10, 2016
Dog Food Maker Settles with FTC Over False Ad Charges
Aug 5, 2016
FDA National DTC Ad Survey Sent to OMB for Review
Aug 4, 2016
N.Y. AG Tells Seven Companies Marketing Anti-Zika Products To Cease and Desist
Aug 3, 2016
Less Formal Enforcement by FDA Reflects Changing Promotional Environment
Jul 30, 2016
BIO and PhRMA Release Principles for Disseminating Truthful and Non-misleading Information
Jul 27, 2016
Acclarent Resolves False Claims Charges Related to Alleged Off-label Marketing for $18 Million
Jul 21, 2016
Two Former Acclarent Executives Convicted in Device Off-label Case; Company Pays $18 M.
Jul 20, 2016
Medical Groups Support Senate Bill Exempting Educational Materials from Sunshine Act Reporting

Good Clinical Practice

Apr 8, 2017
European Medicines Agency Releases Draft Guideline on Multiplicity Issues in Trials
Apr 8, 2017
FDA Delays Mandatory Electronic Submission of Master Files By One Year
Apr 7, 2017
Pa. Bill Clarifies Reimbursement from Inducement To Enter a Cancer Trial
Apr 7, 2017
Pennsylvania Senate Bill Would Allow Minors Access to Investigational Products
Apr 6, 2017
ASCO Supports Strengthening FDA Expanded Access; Opposes State and Federal ‘Right-to-Try’ Measures
Apr 3, 2017
ACRP Starts Certified Professional Program
Apr 3, 2017
UK Provides Guidance on Common Application Errors
Apr 3, 2017
ASCO Issues Recommendations on Observational Research
Mar 28, 2017
EMA Sets Up Technical Group To Develop Best Practices for Anonymizing Trial Data
Mar 24, 2017
Brain Tumor Trial Finder Launched

FDA Regulation & Enforcement

Aug 22, 2019
Guidance Posted on How to Measure, List Certain Items on Updated Labels
Aug 21, 2019
OPDP Wants To Hear About Experiences With Third-Party eCTD Submissions
Aug 21, 2019
Endo Settles with Two Ohio Counties
Aug 16, 2019
CMS Proposes Changes to Open Payments Program
Aug 15, 2019
Court: Arizona Statute Blocks Award of Punitive Damages Against Maker of Device with 510(k) Clearance
Aug 15, 2019
FDA Threatens Enforcement Action Following Disclosure of AveXis Data Manipulation in Zolgensma BLA
Aug 14, 2019
Study: Sesame Allergy More Widespread Than Previously Understood
Aug 14, 2019
Six Companies Breached ABPI Code
Aug 9, 2019
NZ Survey Finds Majority Would Ban DTC Ads If Independent Info Were Available
Aug 9, 2019
Australian Court Fines Company $10 Million For Breaching Medicine Advertising Rules

Medical Devices

Jul 31, 2012
Proposed Effective Dates of UDI Requirements
Jul 31, 2012
New FDA Performance Goals Under MDUFA III
Jun 30, 2012
OIG Recommends More Clarification, Training To Help Resolve Scientific Disagreements at CDRH
Jun 30, 2012
CDRH Gears Up Mobile App for Voluntary Adverse Event Reporting; UDI Scanning Capability Planned
Jun 30, 2012
Spectrum Dedicated to Medical Body Area Networks
Jun 30, 2012
Device Company Owner Charged With Adulteration, Faces Three Years in Prison
May 31, 2012
More Risk-based Approach to Device Trials Urged
May 31, 2012
CDRH Scientists Concerned With Political, Business Influences, Postmarket Safety
May 31, 2012
FDA Draft Guidance Targets Unnecessary Pediatric Radiation Exposure
Apr 30, 2012
FDA's Draft Guidance on Substantial Equivalence Modifies Paradigm, Presents Additional Challenges

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