FDA Inspection Backlog: One-Quarter Of Domestic Visits Can Be Cleared In FY 2021; About 50 NDAs Have Been Delayed Solely Due To COVID Pandemic

FDA Research On “Sameness” For Oligonucleotide Products Is Ongoing; Drug-Device Combos Are Priority For Product-Specific Guidances

Prevision Policy Clips | MCIT Final Rule Defining “Reasonable And Necessary” For Medicare Coverage Will Move Forward

House Pushing HR 3 Drug Pricing Bill (Again) With Dual Hearings; Everyone Agrees There’s A Problem – But Not On The Solution

Biden Administration Backs IP Waiver For COVID Vaccines: One Off Event Or Sign Of Things To Come?

Prevision Policy Clips | HHS Secretary Becerra Will Testify At House E&C Budget Hearing May 12

ChemoCentryx’ Avacopan For AAV: FDA Questions Design And Interpretation Of Single Trial Heading To Panel; “Steroid Sparing” Claim In Doubt Even If Approval Is Supported

Prevision Policy Clips | House E&C Drug Pricing/HR3 Hearing Will Hear Caution On Medicare Inflation Rebates

Advisory Committee Tracker: Another Landmark Diabetes Review In May; Provention May Get Positive Vote, But Approval Very Much In Doubt

Prevision Policy Clips | The Eagle Has Landed Former FDA Chief Scientist Luciana Borio As Board Member

FDA’s Pazdur Reasserts Influence Over ODAC With Split Vote On Opdivo In Second-Line Liver Cancer While Keytruda AA Unanimously Endorsed

Prevision Policy Clips | ODAC Accelerated Approval Review Is 4-2 In Favor Of Maintaining Indications

Merck Keytruda Third-Line Gastric Cancer Approval Likely To Be Pulled; Checkpoint Inhibitors Have Role, FDA Stresses – But Should Be At Earlier Stage

FDA Developing “N of 1” Therapy Requirements With Eye To Building Sustainable Business Models; CBER Needs 100 More Staffers To Meet Need, Marks Says

NTAP Extensions Proposed By CMS: Andexxa, Spravato Among Drugs In Line For Extra Year Of Enhanced Inpatient Payment By Medicare

Genentech’s Tecentriq, Merck’s Keytruda Take Different Routes To Protect Urothelial Indications: Coming-Soon Final Data; Continuing Unmet Need

Prevision Policy Clips | FDA Sends Shot Across The Bow For Industry On ClinicalTrials.Gov Noncompliance With Notice To Acceleron Pharma

Keytruda, Opdivo Accelerated Approval Reviews May Hinge On “Changing Landscape” In Liver Cancer; Do New Treatments Make Them Obsolete?

Genentech Tecentriq Accelerated Approval Should Be Maintained For Triple Negative Breast Cancer, FDA Committee Says, After Glitch-Filled Meeting

Prevision Policy Clips | Biden Will Reiterate Support For Rx Price Negotiation, But Not In His Infrastructure Bill

Antisense Oligonucleotide Nonclinical Testing Guidance Outlines Abbreviated Safety Package, Dose Selection

ICER Has Advice For FDA On Accelerated Approval Pathway; Value Assessment Group Also Offers More Dramatic Overhaul Ideas

Prevision Policy Clips | TIRF REMS Update Causing Issues For Patients, FDA Acknowledges

Merck Keytruda 1st Line Urothelial Cancer Indication May Be In Stronger Position Than Genentech’s Tecentriq Heading Into ODAC Meeting

Keytruda Gastric Cancer Indication Faces Tough Challenge During ODAC Accelerated Approval Review; Low Use May Make For Easier Withdrawal