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FDA Draft Guidance Encourages Flexible Designs To Enroll “Older Adults” In Cancer Trials, With Special Focus On The Over-75 Population
March 5, 2020
Prevision Policy Clips | FDA’s First Budget Hearing Set For March 11
March 5, 2020
COVID-19 Funding Bill Includes $61 Million For FDA, $3.1 Billion For Countermeasures: “Fair” Pricing Language Cites Government Contracting Rules
March 4, 2020
“Deeming Day” Final Preparations: FDA Says NDC Codes Should Not Change, Maintains Five-Year Timeline For Sponsors To Update Labels
March 4, 2020
Pharmaceutical Nationalism: Senate Coronavirus Hearing Spotlights Foreign API Dependence; Commissioner Hahn’s Baptism By Fire
March 4, 2020
Prevision Policy Clips | “Deeming Day” Final Preparations: FDA Says NDC Codes Should Not Change, Maintains Five-Year Timeline For Sponsors To Update Labels
March 4, 2020
Prevision Policy Clips | HHS, CMS, DEA To Testify On Substance Use Bills
March 3, 2020
Prevision Policy Clips | Supreme Court To Hear Texas ACA Challenge In The Fall, Drug Pricing In Limbo Until 2021?
March 2, 2020
Prevision Policy Clips | First Drug Shortage Related to Coronavirus; FDA Not Disclosing Name
February 28, 2020
Advisory Committee Tracker: GSK Trelegy Mortality Claim Highlights Trio Of Newly Announced Reviews
February 27, 2020
Lilly Cyramza First-Line Lung Cancer Claim Narrowly Clears Committee; The Long Shadow Of Avastin Lingers – But Lilly’s Reputation May Help Garner Approval
February 27, 2020
Rare Disease Center Of Excellence Pushed By EveryLife: FDA Has Authority But Congress Being Asked To Weigh In; Possible “Cures 2.0” Theme
February 27, 2020
Prevision Policy Clips | Drug Importation Proposed Rule: HHS Secretary Azar Welcomes Legislative Fix For Insulin
February 27, 2020
Steba’s Tookad For Early-Stage Prostate Cancer Shot Down By FDA Advisory Committee; Confirmatory Trial Results Expected In 2030
February 26, 2020
Gene Therapies For Rare Diseases: Strong Natural History Studies And N-Of-Some Trials Headline Meeting; FDA Commissioner Hahn Makes A Debut
February 26, 2020
Prevision Policy Clips | Gilead Remdesivir Randomized Trial Results Expected “Reasonably Soon”
February 26, 2020
Drug Pricing Takes Back Seat To Coronavirus In Latest HHS Budget Hearing; Debate On Overseas API, Shortages Could Have Longer-Term Impact on Pharma
February 25, 2020
Prevision Policy Clips | ODAC Reviews Will Test Accelerated Approval, Show Expectations For PFS v. Survival In First Line Lung Cancer
February 25, 2020
Steba Takes Tookad To FDA Committee For Early Prostate Cancer: Novel “Prevent/Delay” Endpoint Will Test Accelerated Approval Parameters
February 24, 2020
Lilly Cyramza First-Line Lung Cancer Claim: FDA Review Suggests Survival Benefit Needed For Approval – But Strong PFS May Work One Last Time
February 24, 2020
Hahn’s FDA Prepares For “Deeming Day”: NDA-BLA Transition Marks Early Milestone In New Commissioner’s Tenure
February 24, 2020
Prevision Policy Clips | FDA Rare Disease Division Leadership Still Unsettled Following Departure Of Dragos Roman
February 24, 2020
Prevision Policy Clips | FDA “Class Of 2019” NME Profile: Seven Products Were Approved Based On US-Only Trials
February 21, 2020
FDA’s “Technology Modernization Action Plan” Moves To First Tangible Projects; Streamlined IND Safety Reporting Is An Early “Living Example”
February 20, 2020
FDA Guide To Pharmacogenomic Tests Includes Three “Unapproved” Drug Claims; Effort To Guide Consumers Underscores Gaps In Regulatory Framework
February 20, 2020
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