Woodcock Touts Medical Device Actions 07/21/2021

Flexibility, Engagement are Covid Lessons for CDRH: Shuren 07/22/2021

Domestic Inspections Resume Standard Operations 07/20/2021

Statin Pregnancy Contraindication Lifted 07/20/2021

House Committee Wants FDA Drug Inspection Info 07/22/2021

Public Still Trusts FDA, CDC, Fauci: Survey 07/22/2021

Field Alert Report Guidance 07/22/2021

Draft Remanufacturing Guidance Falls Short: Mintz Analysis 07/21/2021

FDA Approvals of High-Risk Medical Devices ‘Way Down’: Post 07/20/2021

Stakeholders Urged to Transform Drug Supply Chain 07/20/2021

3 More Former FDAers Join Greenleaf Health 07/22/2021

Dahlia Center Offering Cellular Product to Treat Covid-19: FDA 07/21/2021

FDA Denies Professor’s Tolvaptan Petition 07/20/2021

Expanded Use of Prograf Relied on RWE 07/19/2021

Shift to Include Pregnant Women in Trials: FDA 07/19/2021

Latest Federal Register Notices 07/25/2021

Since Our Last Issue ... 07/25/2021

Product Approval Summaries 07/25/2021

Class 1 Recall for Philips Respironics’ Ventilators 07/23/2021

Regen Centers Marketing Unapproved Cellular Products: FDA 07/22/2021

FDA Not Meeting PDUFA Dates on 2 Pfizer NDAs 07/22/2021

FDA Seeking New Patient Engagement Collaborative Members 07/22/2021

Covis Seeks FDA Actions on Eugia Pharma ANDA 07/20/2021

Ardelyx Tenapanor NDA Hits FDA Snag 07/19/2021

FDA Accepts Aquestive NDA Resubmission 07/19/2021