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First OPDP Warning Letter of 2019 Focuses on Risk…

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August 27, 2019
FDA, HHS Propose Two Possible Pathways for…

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July 31, 2019
NPRM To Harmonize FDA Rules with Revised Common…

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June 3, 2019
Next FDA Head Will Confront Full Agenda of…

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April 8, 2019
FDA Looks to ‘Tailored Review Framework’ for…

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April 8, 2019

LATEST HEADLINES

Manufacturer, Subsidiary To Pay $9.5 Million To…

September 19, 2019
FDA Announces New Program To Help Speed Safer Devices…

September 18, 2019
Petition Seeks Changes to FSIS Labeling Regulations…

September 18, 2019
EMA Opens Consultation on Pediatric Trial Preparedness

September 16, 2019
California Bill Expands Insurance Coverage of Routine…

September 16, 2019
Study Finds Publication of Heart Failure Trial Results…

September 16, 2019
Court Allows RICO Claims To Continue in Multidistrict…

September 16, 2019
More Hospitals Sue Opioid Makers

September 14, 2019
Pennsylvania Files Lawsuit Against Sackler Family

September 13, 2019
GAO Review Finds Most Drug Makers Have Expanded Access…

September 12, 2019

Latest FDA Intelligence

Opioid Settlements Raise Questions for Future Off-label Marketing Cases

September 8, 2019
2019 OPDP Enforcement Letters Highlight Agency Concern About Risk…

August 5, 2019
OPDP Enforcement Emphasizing Risk Minimization

July 6, 2019
Recent Untitled Letter Offers Blueprint for Handling Risk/Safety…

June 8, 2019
Consumer Education Needed on DTC Ad Info

May 6, 2019

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