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Top News

CDER Issues Warning Letter To Investigator for Failing to Follow Trial’s Investigational Plan

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January 20, 2020
Dr. Stephen Hahn Confirmed as New FDA Commissioner

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December 12, 2019
OPDP Issues Third Warning Letter for 2019

Full Article

December 11, 2019
CBD: To Be or Not To Be a Supplement Ingredient; Petition Seeks a Go-ahead From FDA

Full Article

December 5, 2019
FDA Warns of National Shortage of Devices Due to Closures of Ethylene Oxide Sterilization Facilities

Full Article

October 29, 2019

LATEST HEADLINES

CDER Issues Warning Letter To Investigator for Failing to Follow Trial’s Investigational Plan

January 20, 2020
Endo Settles with Oklahoma Over Opioid Marketing

January 19, 2020
Sleep Apnea DME Manufacturer To Pay More than $37.5 Million To Resolve Kickback Allegations

January 17, 2020
FDA Finalizes New Food Labeling Serving Size Guidance

January 16, 2020
Former Insys Executive Sentenced to 33 Months in Prison for Role in Prior Authorization Scheme

January 15, 2020
FDA Exempts Powered Wheeled Stretchers from 510(k) Mandates in Response to Stryker Petition

January 15, 2020
FDA Revises Procedures for Drug Preapproval Inspections To Outline Collaboration by ORA, CDER Staff

January 14, 2020
NASEM Plans February Workshop on Ethical Issues in New Biomedical Research

January 10, 2020
Consent Decree Shuts Down New York-Based Dietary Supplement Manufacturer After Repeated cGMP Violations

January 9, 2020
NLM Issues Request for Information To Aid Modernization of ClinicalTrials.gov

January 8, 2020

Latest FDA Intelligence

FDA’s New CURE ID Program Could Affect Wide Spectrum of Off-label Issues

January 7, 2020
Trends Seen in 2019 OPDP Enforcement Letters

December 6, 2019
Untitled Letter Provides Reminder of Rules for Patient Testimonials

November 15, 2019
Does Recent Warning Letter Indicate OPDP Plans More Aggressive Enforcement?

October 6, 2019
Opioid Settlements Raise Questions for Future Off-label Marketing Cases

September 8, 2019

NEWSLETTERS

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Top News

CDER Issues Warning Letter To Investigator for Failing to Follow Trial’s Investigational Plan

Dr. Stephen Hahn Confirmed as New FDA Commissioner

OPDP Issues Third Warning Letter for 2019

CBD: To Be or Not To Be a Supplement Ingredient; Petition Seeks a Go-ahead From FDA

FDA Warns of National Shortage of Devices Due to Closures of Ethylene Oxide Sterilization Facilities

LATEST HEADLINES

Latest FDA Intelligence

FDA’s New CURE ID Program Could Affect Wide Spectrum of Off-label Issues

Trends Seen in 2019 OPDP Enforcement Letters

Untitled Letter Provides Reminder of Rules for Patient Testimonials

Does Recent Warning Letter Indicate OPDP Plans More Aggressive Enforcement?

Opioid Settlements Raise Questions for Future Off-label Marketing Cases

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