Gottlieb Outlines New Diagnostics Regulatory Framework 09/13/2018

Trump Admin Taps Inside Counsel as Top FDA Lawyer 09/10/2018

CNS Drugs Longer to Develop, Approve: Tufts Center 09/11/2018

Streamlining Third-Party Device Reviews 09/13/2018

Integrate Cybersecurity in Medical Device Reviews: OIG 09/11/2018

PMRS Sues FDA Over Hearing on Rejected NDA 09/14/2018

FDA Proposes Cutting Device Submission Copies 09/12/2018

2 Voluntary Consensus Standards Guidances 09/13/2018

Ex-FDA Top Lawyer Returns to Sidley Austin 09/11/2018

FDA Finds Violations in 2 Medtronic Inspections 09/11/2018

FDA Making FOIA Changes in Info Regs 09/12/2018

Latest Federal Register Notices 09/16/2018

Since Our Last Issue ... 09/16/2018

Product Approval Summaries 09/16/2018

Safety Alert on Alcon’s CyPass Micro-Stent 09/14/2018

5 Observations from Cook Pharmica Inspection 09/13/2018

Unichem Laboratories FDA-483 09/13/2018

PharmD Solutions Recalls Compounded Drugs 09/13/2018

Unexpected Impurity in Some Valsartan Products 09/13/2018

Yuki Gosei Kogyo Inspection Observations 09/13/2018

54 Product-Specific Drug Guidances Out 09/13/2018

Attorneys Analyze Medical Device Guidance ‘Flood’ 09/12/2018

Pediatric Medical Device Development Grants 09/12/2018

FDA Issues Sun Pharmaceutical FDA-483 09/12/2018

Latest FDA Warning Letters 09/11/2018

CGMP Violations Found in Lernapharm Inspection 09/11/2018

Comments on Draft Indications and Usage Labeling Guidance 09/11/2018

‘Procedural Deficiency’ in Lupin Tarapur Inspection 09/11/2018

CGMP Violations at China’s Longwood Medicine (Beijing) 09/11/2018

More Data Needed on Glaxo COPD Add-on Drug 09/10/2018