AI In Drug Development: Avoid The “Flashiness” Of Digital Health Technologies, FDA’s ElZarrad Cautions, And Simply Ask: “Does It Fit?”

FDA Rare Disease START Inaugural Class Has Three Gene Therapies, Including Rett Syndrome And NGLY1 Deficiency; CBER Oversubscribes Based On Interest

Prevision Policy Clips | FDA's Psychopharmacologic Drugs Advisory Committee Rejects Lykos Therapeutics’ MDMA For PTSD

Prevision Policy Clips | FDA Bioresearch Monitoring (BIMO) Inspections Guidance Details Processes, Best Practices

Prevision Policy Clips | START Rare Disease Pilot Program Participants Selected, FDA Says

Lykos’ MDMA For PTSD: Two Positive Trials But Large Unblinding Impact; Abuse Potential Is Real, Though FDA Appears Open To Approval With Very Tight REMS

Prevision Policy Clips | FDA “Office Of Inspections & Investigations” Receives Final Approval Ahead Of October 1

Prevision Policy Clips | Lilly Donanemab Committee Review Will Involve Two Members With CoI Waivers

Artificial Intelligence Drug Development Draft Guidance Will Address “What Is Within FDA’s Scope” In Regulating Emerging Field, CDER Policy Official Says

Prevision Policy Clips | House Energy & Commerce Subcommittee Hearing On 340B Scheduled For June 4

Platform Technology Designation Pathway Guidance Released By FDA: Lipid Nanoparticles Are Prominent Example Of Technology Eligible For Designation; Delivery Devices Are Not

Advisory Committee Tracker: High-Profile Meetings Return In June; MDMA, Donanemab And COVID Strain Set Context For Feedback On Committee Use

Prevision Policy Clips | “Platform Technology Designation Program” Draft Guidance Released: FDA Estimates 10 Requests Per Year

Novo’s Once Weekly Insulin Icodec For Type 1 Diabetes Voted Down By FDA Panel Due To Hypoglycemia Risk; Little Appetite For Risk Management, But Type 2 Use Assured

Senate Judiciary Committee Laments Stalled Drug Competition Reforms At Hearing; DTC Advertising, More Active FDA Orange Book Role Are Areas Of Interest

Prevision Policy Clips | Pfizer Receives Medical Countermeasure Priority Review Voucher For Paxlovid

CDER/CBER Rare Disease Innovation Agenda Will Align Regulatory Efforts Under “Shared Vision,” FDA Center Directors Say At House Hearing

Prevision Policy Clips | Division of Oncology II Director Is Erin Larkins Following Departure Of Harpreet Singh

Novo’s Once-Weekly Insulin Icodec: Type 2 Indication Looks Ready For Approval, But Type 1 Use At Risk Ahead Of FDA Advisory Committee Review

Regulatory Flexibility For Rare Diseases: Ex-FDAer Woodcock Endorses New Legislative Pathway; CBER’s Marks Favors Working Under Existing Regs

“Access Plans” Are NIH’s Latest Response To Calls For Price Interventions; Proposal Is Largely Non-Threatening – But Pricing Commitments Could Be Part Of Some Plans

Prevision Policy Clips | “Access Plans” – Potentially Including Pricing Commitments—Will Be Part Of NIH Technology Transfer Agreements

Clinical Trial Diversity: FDA’s Califf Wants Broader Conversation About Global Expectations, More Focus On Subsets – And Maybe Larger Trials

Prevision Policy Clips | OCE “Equity Program” To Be Co-Led By Division Of Hematologic Malignancies 2 Director Nicole Gormley, OCE Director For Regulatory Affairs And Policy Tamy Kim

Project Orbis Update: FDA Nearing 100 Approvals Under Global Oncology Collaboration; Japan, EMA And India Are Focus Of OCE Outreach Efforts