9% Budget Boost for FDA, Biggest in Years 02/14/2019

FDA ‘Least Burdensome’ Guidance ‘Could Be Worse’: Attorney 02/13/2019

New Efforts Mulled to Modernize Dietary Supplement Regulation 02/11/2019

CGMP Violations at Akorn Decatur Plant 02/13/2019

Established Conditions Pilot Program 02/14/2019

FDA Warns McKesson on Opioid Tampering 02/12/2019

Device Makers to Get Nonbinding Feedback on Inspection Findings 02/15/2019

Hill Seeks FDA Briefing on Blood Pressure Drug Recalls 02/13/2019

Janssen Depression Drug Gains Joint Panel Backing 02/13/2019

2 Final Guidances on Regenerative Medicine 02/15/2019

Latest Federal Register Notices 02/18/2019

Product Approval Summaries 02/18/2019

Since Our Last Issue ... 02/18/2019

Medtronic Recall of Dual Chamber Implantable Pulse Generators 02/15/2019

Vasisht Office of Women’s Health Deputy 02/14/2019

QS Issues at Circulatory Technology 02/14/2019

Issues Raised on Proposed IRB Consent Waiver 02/14/2019

FDA OKs 1st Interoperable Insulin Pump 02/14/2019

FDA Asked to Explain Dsuvia Approval 02/13/2019

Immunomedics FDA-483 Has 13 Observations 02/13/2019

Samson Pharmaceuticals Inspection Finds CGMP Issues 02/13/2019

Draft CDER Consensus Standard Guidance 02/13/2019

LC Medical Concepts Warned on Wound Kit Manufacturing 02/13/2019

4 Former FDAers Join Parexel 02/12/2019

FDA Releases Lupin Limited FDA-483 02/12/2019

FDA Appoints New Generic Drugs Director 02/12/2019

Latest FDA Warning Letter 02/12/2019