Drop in FDA Enforcement Noted 07/08/2019

Grassley, Durbin Want Ad Drug Prices 07/10/2019

Reckitt Benckiser Settles Suboxone Marketing Cases for $1.4 Billion 07/11/2019

FDA Recognizes All EU States Under MRA 07/11/2019

Rare Disease R&D is Active Development Area: Tufts 07/09/2019

FDA Releases Dr. Reddy’s FDA-483 07/09/2019

Population Pharmacokinetics Draft Guidance 07/11/2019

Hormonal Drug Effectiveness, Safety Guidance 07/11/2019

Pennsylvania Courts Assess Medical Device Strict Liability 07/11/2019

Latest Federal Register Notices 07/14/2019

Product Approval Summaries 07/14/2019

Since Our Last Issue ... 07/14/2019

Altaire Recalls OTC Eye Drops 07/12/2019

Warning Letter Issued After IRB Inspection 07/12/2019

GE Healthcare Recalls Infant Warmers 07/12/2019

Omeros, FDA Agree on Narsoplimab Primary Endpoint 07/11/2019

FDA Qualifies Device Assessment Model Tool 07/11/2019

Medicare Part D Opioid Use Down: OIG 07/10/2019

Apokyn ANDAs Should Cover Drug and Device Parts: Petition 07/10/2019

2 DoJ Whistleblower Policies Explained 07/10/2019

2 Guidances to Speed Generic Drug Development 07/10/2019

Live Case Presentations in Device Trials Guide 07/10/2019

Remove Amarin Corp. Patent from Orange Book: Petition 07/10/2019

Leverage Facebook Health Support Groups: CMI/Compas 07/10/2019

Quality System Violations in Clinicon Inspection 07/09/2019

Latest FDA Warning Letters 07/09/2019

FDA Prioritizing Review of ANDAs to Treat Opioid Overdose 07/08/2019