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FDA Working With BARDA On Mobile, On-Demand Manufacturing; Agency Is Looking At Regulatory Changes For Systems That Could Address Shortages
November 4, 2019
Prevision Policy Clips | CMS Maintains 340B Payment Cut, Exparel Payment Policies
November 4, 2019
Giroir’s FDA: New Acting Commissioner Has Strong Resume, Close Ties to HHS Secretary Azar; Tenure Could Be Prolonged If Hahn Confirmation Bogs Down
November 1, 2019
Prevision Policy Clips | FDA Commissioner Nominee: White House May Be Working With Nov. 5 Deadline
November 1, 2019
Agile Contraceptive Patch Recommended For Approval By Wide Margin – Taking FDA To A Place It Does Not Want To Go
October 31, 2019
Advisory Committee Tracker: Product Reviews Are Getting Rarer For A Reason – FDA Managers Appear To Be Losing Faith In Quality Of Advice
October 31, 2019
Manufacturer “Quality Maturity” Rating Proposed By FDA In Shortage Report; Task Force Output Reflects Shortage Of New Ideas As Well As Old Drugs
October 31, 2019
Prevision Policy Clips | Hepatitis D Drug Development Draft Guidance
October 31, 2019
Makena Withdrawal Narrowly Supported By FDA Committee; Process Would Likely Take At Least 18 Months – If Agency Decides Fight Is Worth It
October 30, 2019
Prevision Policy Clips | Countdown To FDA Nomination? Acting Commissioner Sharpless Has Less Than 48 Hours
October 30, 2019
OND Update: Review Office Reorganization Will Commence In November; Oncology, Neuroscience And Infectious Disease Offices Are First For Revamp
October 29, 2019
Prevision Policy Clips | FDA Gets Congressional Forum For Drug Shortages Report And Market Reform Suggestions
October 29, 2019
Agile’s Twirla Heads To Committee: Third Strike Likely For Patch Contraceptive; FDA Sees “Unacceptable” Efficacy Shortfall
October 28, 2019
Prevision Policy Clips | Combo Products With Electronic/Software “Platform” Drug Master File Guidance Issued October 28
October 28, 2019
Makena Status In Doubt On Two Fronts: Failure To Confirm Clinical Benefit And Lack Of Evidence For Surrogate, FDA Says; Enough To Pull Standard Of Care?
October 25, 2019
Prevision Policy Clips | OTC Monograph Reform Resurfaces: Senate HELP Markup Scheduled
October 25, 2019
Mandatory Post-Marketing Studies: FDA Affirms Wide Scope Of New Authority To Order Trials For “Reduced Effectiveness” In Updated Draft Guidance
October 24, 2019
CMS Administrator Faces Critics In House Oversight Hearings; Republicans Use Event To Seek Ideas On Value-Based Payment Options
October 24, 2019
Prevision Policy Clips | International Drug Manufacturing Will Be Focus Of House Supply Chain Hearing October 30
October 24, 2019
HR3 Heads To House Floor: Upcoming Vote Could Allow Return To Bipartisan Part D Talks; Time For Biopharma To Rebuild Innovation Defense
October 23, 2019
Prevision Policy Clips | HR3 On Track For House Floor Vote Oct. 28; Marathon Mark-Up Leads To Predictable Result
October 23, 2019
White House On HR3: Only “Red Line” Is No New Money For ACA
October 22, 2019
Prevision Policy Clips | A Big Test For FDA: Biogen Plans To Submit Aducanumab For Alzheimer’s After All
October 22, 2019
FDA Expands “Cures” Hiring Authority To Fill Range Of Open Positions; 80 Appointments Made To Date
October 21, 2019
Prevision Policy Clips | Ways & Means HR 3 Markup October 22
October 21, 2019
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