What Grounded Boeings and FDA Have in Common 03/15/2019

FDA Steps to Modernize Clinical Trials 03/14/2019

NCI Head Sharpless Appointed FDA Acting Commissioner 03/12/2019

CDRH Reorganizes for Total Product Life Cycle 03/13/2019

Trial Enrichment Strategies Guidance 03/14/2019

FDA Finds Increased Mortality with Paclitaxel Devices 03/15/2019

5 Cancer Trial Eligibility Guidances 03/12/2019

CGMP Violations at Hospira Healthcare India 03/12/2019

Covidien Settling False Claims Act Case for $17 Million 03/12/2019

Risk-Based Investigation Guidance 03/14/2019

Promoting Unapproved Drugs is OPDP Focus: Analysis 03/13/2019

Guidance on Devices with Animal Source Materials 03/14/2019

Court Denies Summary Judgment in Teva Whistleblower Case 03/13/2019

FDA Blocks PMA Approvals from Integra Subsidiary 03/11/2019

Since Our Last Issue ... 03/17/2019

Latest Federal Register Notices 03/17/2019

Product Approval Summaries 03/17/2019

Advisory Panel to Mull Device Metal Hypersensitivity 03/15/2019

Spectrum BLA for Rolontis Withdrawn After FDA Request 03/15/2019

Guilty Pleas in Fraudulent Supplement Sales Scheme 03/14/2019

2 EIRs Issued to Pharmaceutics International 03/14/2019

Hematologic Disorder Drug Development Guidance 03/14/2019

10 Observations on Genetech FDA-483 03/13/2019

4 Observations in Immunomedics FDA-483 03/13/2019

Software Precertification Program Comments 03/12/2019

Guardian Pharmacy Services Consent Decree 03/12/2019

Latest FDA Warning Letters 03/12/2019

Biocon FDA-483 03/12/2019

FDA Qualifies 1st Biomarker Test Tool Type 03/12/2019