BI/Lilly Empagliflozin For Type 1 Diabetes: FDA Asks Ad Com If Clinical Effect Is Too Small; 2.5 mg Dose Proposed Based On One Study

OND Feedback Meeting: New Division Director Line-Up Debuts In Listening Mode; Key Theme Is Be More Like Oncology

Merck Seeking Add-On Payment For Five-Year-Old Antibiotic; Seven Anti-Infectives, Two CAR-Ts Among Those Seeking NTAP Status In 2021

DoD and VA Drug Procurement Should Prefer Domestic Production, Witnesses Tell House Supply Chain Hearing; Over-Reliance On Chinese Supply Is Concern

Prevision Policy Clips | FDA Oncology Center Of Excellence Gains Patricia Keegan As Acting Associate Director

FDA’s Message On Manufacturing: GMP Adherence Is Not “Good Enough,” But Industry Will Have Chance To Shape “Quality Maturity” Program

FDA’s Office of Neuroscience Will Be Tested In 2020 With High-Visibility Reviews; Bastings To Lead Division Overseeing Alzheimer’s, DMD Drugs

Prevision Policy Clips | Can FDA Nominee Hahn Be Confirmed In Six Weeks?

ICER Reviews Are New Frontier For Patient Groups; Organizations Feel Compelled To Participate Despite Effort Required, Advocates Tell BIO

FDA Oncology Office Has Four New Division Directors, With Keegan Moving To OCE; Neurology, Infectious Disease Offices Have Fewer Changes; Most Deputies Are TBD

Prevision Policy Clips | FDA Seeks Comments On Best Practices Document For Drug/Biologic Postmarket Safety Surveillance

Prevision Policy Clips | The “New” OND: November 7 Launch Meeting Will Feature CDER Deputy Cavazzoni

FDA Working With BARDA On Mobile, On-Demand Manufacturing; Agency Is Looking At Regulatory Changes For Systems That Could Address Shortages

Prevision Policy Clips | CMS Maintains 340B Payment Cut, Exparel Payment Policies

Giroir’s FDA: New Acting Commissioner Has Strong Resume, Close Ties to HHS Secretary Azar; Tenure Could Be Prolonged If Hahn Confirmation Bogs Down

Prevision Policy Clips | FDA Commissioner Nominee: White House May Be Working With Nov. 5 Deadline

Agile Contraceptive Patch Recommended For Approval By Wide Margin – Taking FDA To A Place It Does Not Want To Go

Advisory Committee Tracker: Product Reviews Are Getting Rarer For A Reason – FDA Managers Appear To Be Losing Faith In Quality Of Advice

Manufacturer “Quality Maturity” Rating Proposed By FDA In Shortage Report; Task Force Output Reflects Shortage Of New Ideas As Well As Old Drugs

Prevision Policy Clips | Hepatitis D Drug Development Draft Guidance

Makena Withdrawal Narrowly Supported By FDA Committee; Process Would Likely Take At Least 18 Months – If Agency Decides Fight Is Worth It

Prevision Policy Clips | Countdown To FDA Nomination? Acting Commissioner Sharpless Has Less Than 48 Hours

OND Update: Review Office Reorganization Will Commence In November; Oncology, Neuroscience And Infectious Disease Offices Are First For Revamp

Prevision Policy Clips | FDA Gets Congressional Forum For Drug Shortages Report And Market Reform Suggestions

Agile’s Twirla Heads To Committee: Third Strike Likely For Patch Contraceptive; FDA Sees “Unacceptable” Efficacy Shortfall