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Top News

DOJ Prioritizes Enforcement Targeting COVID-19 Fraud; Court Shuts Down Website Offering Fake Vaccine

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April 1, 2020
CDRH Updates Medical Device Companies on Agency’s Priorities During COVID-19 Outbreak

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March 25, 2020
FDA, EMA Issue Guidance on Conducting Trials During COVID-19 Pandemic

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March 20, 2020
FDA Postpones Most Foreign Inspections Through April Because of Global COVID-19 Outbreak

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March 11, 2020
OPDP Issues First Warning Letters of 2020

Full Article

March 9, 2020

LATEST HEADLINES

FDA Ends Clinical Data Summary Pilot Program

April 3, 2020
FDA, FSIS Offer Labeling Flexibilities in Response to COVID-19

April 2, 2020
DOJ Prioritizes Enforcement Targeting COVID-19 Fraud; Court Shuts Down Website Offering Fake Vaccine

April 1, 2020
District Court Dismisses Qui Tam Case Against Novartis Over Speaker Program

April 1, 2020
FDA Extends Enforcement Discretion for Sterilizers, Air Purifiers, Gowns, Gloves During COVID-19 Crisis

March 31, 2020
FDA Digital Health Policies Offer Leeway for Development of COVID-19 Software and Apps, Agency Says

March 30, 2020
SACHRP: HHS Needs To Issue Guidance on License and Service Agreements for Apps Used in Research

March 27, 2020
Saudi Survey Assesses DTC Advertising

March 26, 2020
FDA Will Not Enforce Onsite Audit Mandates Under Three FSMA Regulations During COVID-19 Emergency

March 25, 2020
CDRH Updates Medical Device Companies on Agency’s Priorities During COVID-19 Outbreak

March 25, 2020

Latest FDA Intelligence

OPDP Shows Concern About Lack of Risk Information in Electronic Communications

March 15, 2020
Industry Needs To Watch OPDP Research’s Impact on Policy

February 4, 2020
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

NEWSLETTERS

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Top News

DOJ Prioritizes Enforcement Targeting COVID-19 Fraud; Court Shuts Down Website Offering Fake Vaccine

CDRH Updates Medical Device Companies on Agency’s Priorities During COVID-19 Outbreak

FDA, EMA Issue Guidance on Conducting Trials During COVID-19 Pandemic

FDA Postpones Most Foreign Inspections Through April Because of Global COVID-19 Outbreak

OPDP Issues First Warning Letters of 2020

LATEST HEADLINES

Latest FDA Intelligence

OPDP Shows Concern About Lack of Risk Information in Electronic Communications

Industry Needs To Watch OPDP Research’s Impact on Policy

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

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