FDA Quality Guide on Real World Data Coming 09/09/2019

FDA Aims to Ban Flavored e-Cigarettes 09/11/2019

Public Citizen Sues FDA Seeking Cesium Chloride Ban 09/10/2019

FDA Biosimilar Bioanalytical ‘Best Practices’ Coming 09/13/2019

Four 510(k) Guidances Out 09/12/2019

FDA Denies Petition Seeking New Opioid Moratorium 09/09/2019

Carcinogen NDMA Now Spreads to Heartburn Drugs 09/13/2019

Courts Let Companies Keep Drug Risks Secret: Reuters 09/11/2019

Suggestions for Use Instructions Guidance 09/11/2019

‘Fabulous’ Science is ‘Not Enough’: Woodcock 09/11/2019

Sterigenics Sterilization Facility Temporarily Closed 09/13/2019

Modeling Tool for Coronary Artery Disease Cleared 09/12/2019

Some Post-Approval Studies Need a Long Time: Opinion Post 09/10/2019

Ipca Laboratories FDA-483 09/10/2019

2 FDA Guidances on De Novo Device Requests 09/09/2019

Latest Federal Register Notices 09/15/2019

Since Our Last Issue ... 09/15/2019

Product Approval Summaries 09/15/2019

Warning on CDK 4/6 Inhibitors Lung Condition 09/13/2019

Advisory Panel to Discuss Vascepa sNDA 09/12/2019

Patent Abuse Leads to Higher Drug Prices: Column 09/12/2019

FDA Clears GE Critical Care Suite 09/12/2019

Treatment Effect Influences FDA Approval Decisions: Study 09/12/2019

Metrix Recalls IV Flexible Bags 09/10/2019

FDA Develops Hepatitis A Immune Response Biomarker 09/10/2019

Abuse, Dependence Labeling Comments 09/10/2019

CluePoints, FDA Clinical Trial Site Selection Model 09/10/2019

Hangzhou Badi CGMP Violations 09/10/2019

Latest FDA Warning Letters 09/10/2019