Real World Evidence on Definitions Under Development: Gottlieb 09/19/2017

Aegerion Pharma Pleading Guilty to Violating REMS 09/22/2017

Lawyer Faults ‘New’ FDA Approach to 510(k)s 09/21/2017

FDA Clears Revamped Pentax Duodenoscope 09/20/2017

Researchers Urge Better FDA Monitoring of Post-approval Studies 09/22/2017

Rep. Paulsen Calls for FDA Reforms 09/18/2017

5th Circuit Backs Solvay False Claims Case Dismissal 09/21/2017

Analytical Similarity Statistical Guidance Out 09/21/2017

Safety Alert Issued on Intercept’s Ocaliva 09/21/2017

Diverse Views on Waxman-Hatch Balance 09/20/2017

Pfizer Says J&J Illegally Blocking Remicade Competition 09/20/2017

Concerns Raised with FDA Priority Submissions Guidance 09/19/2017

Product Approval Summaries 09/24/2017

Since Our Last Issue ... 09/24/2017

Latest Federal Register Notices 09/24/2017

FDA ‘Complete Response’ on Janssen Arthritis BLA 09/22/2017

Public Citizen Sues FDA to Force Benzocaine Ruling 09/21/2017

FDA Warns of Medication-Assisted Treatment Drug Risks 09/20/2017

FDA Warns 13 Web Firms re Unlawful Drug Sales 09/20/2017

FDA Backs Use of Opioid Addiction Drugs Despite Risks 09/20/2017

FDA Panel to Review Resubmitted Testosterone NDA 09/20/2017

FDA Denies BI Petition to Block GSK Trelegy Ellipta 09/19/2017

Medical Device Inspection Changes in Reauthorization 09/19/2017

CGMP Violations at Korea’s Firson Company 09/19/2017

Wuxi Medical CGMP Violations Found 09/19/2017

Pull Propecia and Generics from Market: Foundation 09/19/2017

FDA Concerns with PD-1/PD-L1 Inhibitors Spread to Roche Studies 09/18/2017