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FDA Excipient Review Pilot Could De-Risk Development of Novel Ingredients; Agency Wants Feedback on Idea
December 4, 2019
Prevision Policy Clips | White House Claims HR 3 Impact On R&D Would Offset Savings
December 4, 2019
PDUFA VII: What’s On The Table For The Next FDA User Fee Reauthorization?
December 3, 2019
Antibiotic Labels: Could “Limited Use” Open Up To More Flexible Standards? FDA/IDSA Workshop Highlights Desire For Ways To Communicate Emerging Data
December 3, 2019
FDA Commissioner Nominee Hahn Clears Committee Hurdle, Looks Headed To Confirmation By Full Senate
December 3, 2019
Prevision Policy Clips | “Bespoke” Therapies CBER Workshop March 3:
December 3, 2019
Data Sharing By Drug Sponsors Is Not Generating Flurry Of Negative Lookback Studies; Data Platforms May Not Be Getting Enough Use
December 2, 2019
Prevision Policy Clips | Surprise ODAC: Four Oncology Products Go To Committee Dec. 17-18
December 2, 2019
Prevision Policy Clips | Senate Health Committee Moving Forward On Hahn Nomination For FDA
November 27, 2019
OND Reorg: “Phase III” Delayed To Allow For More Leadership Interviews, FDA Says; Office Directors Confirmed For Most Roles – With One Key Exception
November 26, 2019
Prevision Policy Clips | OND Reorg: “Phase III” Delayed To January 13
November 26, 2019
FDA Biosimilar Insulin Guidance: “Switching” Studies Not Required For Interchangeability, Agency Says, If Analytic Data Is “Robust” Enough
November 25, 2019
Advisory Committee Tracker: Two Big Pharma Cast-Offs Highlight December Agenda – Horizon’s Ophthalmic Teprotumumab And Correvio’s Anti-Arrhythmic Vernakalant
November 25, 2019
Prevision Policy Clips | FDA Rejects Adamis’ High-Dose Naloxone
November 25, 2019
Prevision Policy Clips | Certificates of Confidentiality Draft Guidance
November 22, 2019
Pazdur’s OCE: The Benefits and Risks of Going It Alone At FDA
November 21, 2019
Prevision Policy Clips | Grassley, Wyden Still Searching For 60 Votes On Drug Pricing Bill
November 21, 2019
FDA Regulatory Agenda Includes No Surprises For Year Ahead; Seven Actions By End Of 2019
November 20, 2019
FDA Nominee Hahn Has Smooth Confirmation Hearing: What We Learned About The Potential New Commissioner
November 20, 2019
FDA Core Clinical Outcome Assessment Projects Will Draw On Existing Work: First Three Grants Draw On NIH Work On Physical Function And Pain In Children
November 20, 2019
Prevision Policy Clips | Transdermal/Topical Delivery Systems Subject Of FDA Draft Guidance
November 20, 2019
Novo Frames Rybelus Oral Semaglutide Price In Context Of GLP-1 Class, Not Other Oral Anti-Diabetes Agents; ICER Meeting Looks At Impact Of New Formulation
November 19, 2019
Prevision Policy Clips | House Judiciary Committee Will Mark Up Two Drug-Related Bills Nov. 20
November 19, 2019
Gene Therapy Trial Designs: Endpoints and Biomarkers are Key Issues; Other Suggestions For Improvement -- First-In-Human Dosing, Expanding Inclusiveness in Trials
November 18, 2019
Prevision Policy Clips | Janssen Stelara Medicare Expenditure Investigation
November 18, 2019
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