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Prevision Policy Clips | Calico Life Sciences/AbbVie's Fosigotifator Is Final START Participant
June 7, 2024
FDA’s VRBPAC Favors Single JN.1 COVID Vaccine Formulation For 2024-2025 Season; Ideal Timing For Strain Selection Remains “Elusive,” Agency Says
June 6, 2024
Prevision Policy Clips | How Much Is Too Much? AstraZeneca's Imfinzi Lung Cancer sBLA Heads To ODAC July 25
June 6, 2024
AI In Drug Development: Avoid The “Flashiness” Of Digital Health Technologies, FDA’s ElZarrad Cautions, And Simply Ask: “Does It Fit?”
June 5, 2024
FDA Rare Disease START Inaugural Class Has Three Gene Therapies, Including Rett Syndrome And NGLY1 Deficiency; CBER Oversubscribes Based On Interest
June 5, 2024
Prevision Policy Clips | FDA's Psychopharmacologic Drugs Advisory Committee Rejects Lykos Therapeutics’ MDMA For PTSD
June 5, 2024
Prevision Policy Clips | FDA Bioresearch Monitoring (BIMO) Inspections Guidance Details Processes, Best Practices
June 4, 2024
Prevision Policy Clips | START Rare Disease Pilot Program Participants Selected, FDA Says
June 3, 2024
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
May 31, 2024
Prevision Policy Clips | FDA “Office Of Inspections & Investigations” Receives Final Approval Ahead Of October 1
May 31, 2024
Prevision Policy Clips | Lilly Donanemab Committee Review Will Involve Two Members With CoI Waivers
May 30, 2024
Artificial Intelligence Drug Development Draft Guidance Will Address “What Is Within FDA’s Scope” In Regulating Emerging Field, CDER Policy Official Says
May 29, 2024
Prevision Policy Clips | House Energy & Commerce Subcommittee Hearing On 340B Scheduled For June 4
May 29, 2024
Platform Technology Designation Pathway Guidance Released By FDA: Lipid Nanoparticles Are Prominent Example Of Technology Eligible For Designation; Delivery Devices Are Not
May 28, 2024
Advisory Committee Tracker: High-Profile Meetings Return In June; MDMA, Donanemab And COVID Strain Set Context For Feedback On Committee Use
May 28, 2024
Prevision Policy Clips | “Platform Technology Designation Program” Draft Guidance Released: FDA Estimates 10 Requests Per Year
May 28, 2024
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
May 24, 2024
Senate Judiciary Committee Laments Stalled Drug Competition Reforms At Hearing; DTC Advertising, More Active FDA Orange Book Role Are Areas Of Interest
May 24, 2024
Prevision Policy Clips | Pfizer Receives Medical Countermeasure Priority Review Voucher For Paxlovid
May 24, 2024
CDER/CBER Rare Disease Innovation Agenda Will Align Regulatory Efforts Under “Shared Vision,” FDA Center Directors Say At House Hearing
May 23, 2024
Prevision Policy Clips | Division of Oncology II Director Is Erin Larkins Following Departure Of Harpreet Singh
May 23, 2024
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
May 22, 2024
Regulatory Flexibility For Rare Diseases: Ex-FDAer Woodcock Endorses New Legislative Pathway; CBER’s Marks Favors Working Under Existing Regs
May 22, 2024
“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
May 22, 2024
Prevision Policy Clips | “Access Plans” – Potentially Including Pricing Commitments—Will Be Part Of NIH Technology Transfer Agreements
May 22, 2024
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