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FDA-RELATED NEWS
 
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TXT Verrica Asks FDA to End Ycanth Compounding
10/17/2023
 
 
TXT 6 Observations in Samsung Biologics FDA-483
10/17/2023
 
 
TXT FDA Denies UCB Generic Fintepla Petition
10/17/2023
 
 
TXT Omeros Discontinues Narsoplimab Development
10/16/2023
 
 
TXT Skyrizi Better Than Stelara: AbbVie Data
10/16/2023
 
 
TXT Guide on Testing Pharmaceutical Alcohols
10/16/2023
 
 
TXT Guidance on Diabetic Foot Infection Drugs
10/16/2023
 
 
TXT Aldeyra Tussles With FDA on NDA Data
10/16/2023
 
 
TXT GE HealthCare Update on Neonatal Incubators
10/16/2023
 
 
TXT Priority Review for Tagrisso sNDA in Lung Cancer
10/16/2023
 
 
TXT Device Inspection Compliance Program Revised
10/13/2023
 
 
TXT Hogan Lovells Skeptical of New Generics Pilot
10/13/2023
 
 
TXT FDA OKs Pfizer Ulcerative Colitis Drug
10/13/2023
 
 
TXT InfoBionic Next-Gen Cardiac Monitor
10/13/2023
 
 
TXT FDA to Study Adherence Effect on Promotion
10/12/2023
 
 
TXT Topical Ophthalmic Drug Quality Guidance
10/12/2023
 
 
TXT Stelara Biosimilar Gets ‘Complete Response’
10/12/2023
 
 
TXT Info Collection on Regulatory Misconduct Allegations
10/12/2023
 
 
TXT 3 Stakeholder Comments on FDA QTc Guidance
10/12/2023
 
 
TXT 14 House Dems Want ADHD Drug Shortage Info
10/12/2023
 
 
TXT Fast Track for Glioblastoma Vaccine
10/12/2023
 
 
TXT FDA Sets Digital Health Technologies A/C
10/11/2023
 
 
TXT Cell, Gene Therapy Success Rates Analyzed
10/11/2023
 
 
TXT Breakthrough Devices Could Aid Disadvantaged: Attorneys
10/11/2023
 
 
TXT Senator Calls on FDA to Probe Respironics
10/11/2023
 
 
TXT Former FDAer Beitz Joins Law Firm
10/11/2023
 
 
TXT FDA Needs to Define ‘Substantial Equivalence’
10/11/2023
 
 
TXT Ozempic Kidney Study Stopped Due to Efficacy Data
10/11/2023
 
 
TXT No Care Access Issues in VALOR Trial: Company
10/11/2023
 
 
TXT Cytoxan Not Withdrawn Over Safety/Efficacy
10/11/2023
 
 
TXT Multiple Violations in Abiomed Inspection
10/10/2023
 
 
TXT 2 Unapproved GLP-1 Drug Marketers Warned: FDA
10/10/2023
 
 
TXT Suggested Changes to ‘Underrepresented’ Draft Guide
10/10/2023
 
 
TXT ‘Minor Updates’ to 2 Magnetic Resonance Guidances
10/10/2023
 
 
TXT Researcher Cited for ‘Objectionable Conditions’
10/10/2023
 
 
TXT FDA Cautions About Compounded Ketamine
10/10/2023
 
 
TXT FDA QTc Draft Guidance ‘Too Vague’: NCHR
10/10/2023
 
 
TXT CDRH Plans 24 Guidances in FY 2024
10/10/2023
 
 
TXT FDA Diversity Plan Draft Guidance Due: RAPS
10/10/2023
 
 
TXT Positive Keytruda Data in Lung Cancer: Merck
10/10/2023
 
 
TXT Companion Diagnostic for Retevmo Approved
10/09/2023
 
 
TXT Alnylam Gets ‘Complete Response’ on sNDA
10/09/2023
 
 
TXT Biocon Gets Insulin Aspart BLA Rejection
10/09/2023
 
 
TXT ‘Breakthrough’ Status for Knee Implant
10/09/2023
 
 
TXT 11 Dr. Reddy’s ANDAs Withdrawn
10/09/2023
 
 
TXT HistoSonics De Novo for Tumor Blaster
10/09/2023
 
 
TXT AstraZeneca Seeks More Input on Study Diversity
10/09/2023
 
 
TXT Sun Pharma NDA for Alopecia Areata
10/06/2023
 
 
TXT 2 Covid-19 Product EUAs Revoked
10/06/2023
 
 
TXT Senator Urges Justice Probe of Respironics
10/06/2023
 
 
TXT FDA OKs Zoryve Cream Expanded Use
10/06/2023
 
 
TXT Syndax Reports ‘Positive’ Leukemia Data
10/06/2023
 
 
TXT FDA’s Daunting Task to Tackle Misinformation: Califf
10/06/2023
 
 
TXT FDA Clears Home Hemoglobin Test
10/06/2023
 
 
TXT Clinical Hold for Innate Lacutamab Trials
10/05/2023
 
 
TXT CDRH Marks 10 Years of Cybersecurity Program
10/05/2023
 
 
TXT Reps Reiterate Call for VALID Act Passage
10/05/2023
 
 
TXT FDA Looking Into Counterfeit Ozempic: Report
10/05/2023
 
 
TXT Coherus Refiles Udenyca Onbody BLA Supplement
10/05/2023
 
 
TXT AstraZeneca Comments on FDA QTc Draft Guidance
10/05/2023
 
 
TXT Reagan-Udall Strategies to Understand Regulated Products
10/05/2023
 
 
TXT FDA ‘Unsatisfied’ with Philips Respironics Recall
10/05/2023
 
 
TXT Stimulant Use Disorder Treatment Guidance
10/04/2023
 
 
TXT Medtronic Warns on Stolen Laryngoscopes
10/04/2023
 
 
TXT No Safety Issues in Biosimilar Switches: Study
10/04/2023
 
 
TXT ‘Objectionable Conditions’ at Florida Doctor Site
10/04/2023
 
 
TXT Attorney Blasts CDRH for 8,000-day Petition Delays
10/04/2023
 
 
TXT User Fee Courier Delivery Address Change
10/04/2023
 
 
TXT Moderna Phase 3 Trial for Flu/Covid Vaccine
10/04/2023
 
 
TXT Signature Biologics Illegally Marketing Cord Product
10/03/2023
 
 
TXT Repeat CGMP Deviations at Fresenius Unit
10/03/2023
 
 
TXT Oncology Panel to Discuss Accelerated Approvals
10/03/2023
 
 
TXT More Unannounced Inspections in India: Califf
10/03/2023
 
 
TXT FDA Reviewers Question Amgen’s Lumakras Study
10/03/2023
 
 
TXT AdvaMedDx Challenges Oncology Test Pilot
10/03/2023
 
 
TXT FDA Allows Reformulated Novavax Vaccine
10/03/2023
 
 
TXT Galderma Sent Complete Response Letter
10/03/2023
 
 
TXT Guide on 510(k) eSubmission Template
10/03/2023
 
 
TXT Inspection Derails Lilly Eczema BLA
10/02/2023
 
 
TXT Pilot on ANDA Model-Integrated Evidence
10/02/2023
 
 
TXT Case Study in Corruption: Jeff Shuren’s CDRH
10/02/2023
 
 
TXT Novo Nordisk’s Rivfloza OK’d for Rare Disease
10/02/2023
 
 
TXT FDA Clears AI Heart Failure Detector
10/02/2023
 
 
TXT Government Shutdown Likely This Weekend
09/29/2023
 
 
TXT FDA Proposed Rule on Lab-Developed Tests
09/29/2023
 
 
TXT Graft-versus-Host Disease Guidance
09/29/2023
 
 
TXT De Novo Device E-filing Guide
09/29/2023
 
 
TXT Guide on Drug Dose Banding
09/29/2023
 
 
TXT FDA Approves Biogen’s Actemra Biosimilar
09/29/2023
 
 
TXT Generics Office Expands In-person Meetings
09/29/2023
 
 
TXT De Novo e-Submission Template Guidance
09/28/2023
 
 
TXT Petition Seeks Warning on Fluoroquinolone Guides
09/28/2023
 
 
TXT BrainStorm Cell Therapy Rejected by Panel
09/28/2023
 
 
TXT FDA OKs Amicus Pompe Disease Combo Drugs
09/28/2023
 
 
TXT 265 Suicidal Reports on GLP-1 Drugs: Reuters
09/28/2023
 
 
TXT Physiologic Closed-Loop Control Guidance
09/28/2023
 
 
TXT Graft-vs-Host Product Development Guidance
09/28/2023
 
 
TXT FDA OKs Pfizer’s Bosulif for Pediatric CML
09/27/2023
 
 
TXT Ileus Added to Ozempic Label Adverse Effects
09/27/2023
 
 
TXT Gilead Ends AML Trial of Magrolimab
09/27/2023
 
 
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The most authoritative FDA news analysis each week is found in the pages of Dickinson's FDA Review. Since 1984, this newsletter has been providing in-depth reports on the most significant FDA developments affecting the pharmaceutical, medical device, biologics and veterinary medicines industries. Unlike other media, FDA Review eliminates time-wasting minutia and presents in clear, concise language the essence of what's really important - and why. It is the publication that FDA officials themselves read. Delivered in the middle of each week, FDA Review presents:
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  • Summaries of the latest Warning Letters;
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