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FDA-RELATED NEWS
 
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TXT Suggestions for Biosimilar Research Roadmap
04/11/2023
 
 
TXT CGMP Issues at India’s Champaklal Pharmacy
04/11/2023
 
 
TXT Improve ICH M13A Bioequivalence Guidance: PhRMA
04/11/2023
 
 
TXT FDA Launching Patient Guidance Snapshots
04/11/2023
 
 
TXT Health Misinformation Hurts Life Expectancy: Califf
04/11/2023
 
 
TXT New FDA Cybersecurity Safeguard Requirements
04/11/2023
 
 
TXT Companies Not Ready for New Cyber Safeguards: Article
04/11/2023
 
 
TXT FDA Sets Device Radiation Sterilization File Pilot
04/11/2023
 
 
TXT Regulatory Reforms Needed for AI Devices: Shuren
04/11/2023
 
 
TXT Mifeprex Judge Damns FDA for Worse Abortion Outcomes
04/10/2023
 
 
TXT What of FDA’s Gold Standard After Kacsmaryk?
04/10/2023
 
 
TXT Panel to Mull Leqembi Confirmatory Study
04/10/2023
 
 
TXT Sarepta Duchenne BLA Heads to Panel
04/10/2023
 
 
TXT Reach Neuro Wins ‘Breakthrough’ for Stroke Stimulator
04/10/2023
 
 
TXT DoJ Formally Appeals Mifepristone Texas Order
04/10/2023
 
 
TXT Merck, Eisai Discontinue Melanoma Trial
04/10/2023
 
 
TXT Horizon Therapeutics Touts Thyroid Eye Disease Data
04/10/2023
 
 
TXT Phillips Recalls DreamStation Breathing Devices
04/07/2023
 
 
TXT Two Imbruvica Accelerated Approvals Withdrawn
04/07/2023
 
 
TXT Rep. Kim Reintroduces Drug Recall Authority Bill
04/07/2023
 
 
TXT Florida Gets $600K in Cochlear Implants Case
04/07/2023
 
 
TXT FDA Explores AI Image Analysis for Complex Drugs
04/07/2023
 
 
TXT Boost Faith in Accelerated Approvals: Researchers
04/06/2023
 
 
TXT RSVpreF Vaccine Meets Endpoints
04/06/2023
 
 
TXT Mutagenic Impurities Guideline Adopted
04/06/2023
 
 
TXT FDA Wants MDUFA 5 PPI Input
04/06/2023
 
 
TXT FDA Pulls Makena Approval Immediately
04/06/2023
 
 
TXT FDA Clears restor3D 510(k) for Ankle Device
04/06/2023
 
 
TXT 2 Texas Men Plead Guilty to Misbranded Drug Sales
04/06/2023
 
 
TXT Endpoint Clinical Outcome Assessment Guidance
04/05/2023
 
 
TXT 3 Ex-Magellan Officials Charged Over Device Malfunctions
04/05/2023
 
 
TXT Multiple Violations in Aspire Pharma Inspection
04/05/2023
 
 
TXT Withdraw Wakix Approval: Scorpion Capital Petition
04/05/2023
 
 
TXT Lab Tests Could be in Preparedness Bill
04/05/2023
 
 
TXT QuVa Pharma FDA-483
04/05/2023
 
 
TXT CDER is in Growth Mode from Hiring Spree: Cavazzoni
04/05/2023
 
 
TXT FDA on Pharmacodynamic Biomarker Research
04/04/2023
 
 
TXT Docket Open for Opioids Home Disposal REMS
04/04/2023
 
 
TXT FDA Selecting Fall Covid Vaccine Make-up in June
04/04/2023
 
 
TXT OCP IND Prioritization, Triage Guidance
04/04/2023
 
 
TXT Guide on Animal Drug Human Safety Assessments
04/04/2023
 
 
TXT Abbott Safety Notice on FreeStyle Libre Readers
04/04/2023
 
 
TXT Tavo-EP/Keytruda Fails Phase 2 Melanoma Trial
04/04/2023
 
 
TXT Synovo Adulterated, Misbranded Products
04/04/2023
 
 
TXT FDA ‘Consistent’ in Implementing NME Communications
04/04/2023
 
 
TXT EUA for Gohibic for Some Hospitalized Covid Patients
04/04/2023
 
 
TXT BC3 Tech Clears SEAL Rapid Wound Spray
04/03/2023
 
 
TXT Opioid Makers Must Provide Mail-back Envelope
04/03/2023
 
 
TXT Untitled Letter to Minneapolis Regenerative Medicine
04/03/2023
 
 
TXT Deficiencies Found in Ascendis Pharma NDA: FDA
04/03/2023
 
 
TXT 54% of Confirmatory Studies Are Late Meeting Deadlines
04/03/2023
 
 
TXT Guide on Harmonized Medicinal Product Identification
03/31/2023
 
 
TXT U.S. Government Sides with Generics in Labeling Case
03/31/2023
 
 
TXT Datascope Recalls Cardiosave and Hybrid Pumps
03/31/2023
 
 
TXT FDA Hits India Drug Maker with 14-page 483
03/31/2023
 
 
TXT Bill Would Prevent ANDA Blocking on 1st Generics
03/31/2023
 
 
TXT FDA Evaluating Adult Dental Device Concerns
03/30/2023
 
 
TXT Midwest Vet Supply Forfeits $10 Million for Misbranding
03/30/2023
 
 
TXT AI/ML Software Marketing Submission Guidance
03/30/2023
 
 
TXT VALID Act Reintroduced
03/30/2023
 
 
TXT Research on Some Child Subjects Guidance
03/30/2023
 
 
TXT Align Global Gene, Cell Therapy Regulation: Marks
03/30/2023
 
 
TXT FDA Converts 1 Keytruda Indication to Full Approval
03/30/2023
 
 
TXT Califf Says GOP Budget Cuts Would Devastate FDA
03/30/2023
 
 
TXT Device Cybersecurity Enforcement Discretion
03/29/2023
 
 
TXT ‘Objectionable Conditions’ in Med School Pediatric Trials
03/29/2023
 
 
TXT AI/ML Proliferation Leading to Many Issues: Attorney
03/29/2023
 
 
TXT FDA, Alliance Launch Lupus ABC
03/29/2023
 
 
TXT Emergent Bio Gains OTC Approval of Narcan Spray
03/29/2023
 
 
TXT FDA Shifting Accelerated Approval Approach: Attorneys
03/29/2023
 
 
TXT Non-Spinal Orthopedic Plate 510(k) Guidance
03/28/2023
 
 
TXT Court Orders Release of FDA Vanda Info
03/28/2023
 
 
TXT IND Not Submitted for Cornea Associates Trials: FDA
03/28/2023
 
 
TXT House Committee Questions FDA Drug Shortage Actions
03/28/2023
 
 
TXT Guide on Animal Studies for Devices
03/28/2023
 
 
TXT Cell, Gene Therapy Application Backlog Questioned
03/28/2023
 
 
TXT Bipartisan Bill on Interchangeable Biologics
03/28/2023
 
 
TXT Labeling Changes Approved for 2 Hedgehog Inhibitors
03/28/2023
 
 
TXT Guide on Animal Studies for Devices
03/27/2023
 
 
TXT Under Protest, Brainstorm Resubmits BLA for NurOwn
03/27/2023
 
 
TXT FDA Resumes Generic Drug In-person Meetings
03/27/2023
 
 
TXT Alternative 510(k) Pathway for Contact Lenses
03/27/2023
 
 
TXT Iovance Biotherapeutics BLA for Melanoma Therapy
03/27/2023
 
 
TXT Two Final Guides on Covid-19 Device Transition
03/24/2023
 
 
TXT Accelerated Approval Guide Pushes Randomized Trials
03/24/2023
 
 
TXT FDA Keeping Close Eye on Social Media Promotion
03/24/2023
 
 
TXT New CDRH Web Page on Diagnostic Data Program
03/24/2023
 
 
TXT Panel Backs Accelerated OK Consideration of Biogen's ALS Drug
03/23/2023
 
 
TXT FDA Digital Health Technologies Framework
03/23/2023
 
 
TXT Xtrava Covid Test Less Effective with Some Variants: FDA
03/23/2023
 
 
TXT Unibody Endografts Don’t Beat Older Ones: Study
03/23/2023
 
 
TXT FDA Reminds on Recalled Exactech Joint Devices
03/23/2023
 
 
TXT Dupixent Meets Key Phase 3 Endpoints: Regeneron
03/23/2023
 
 
TXT Workforce, Education for Regenerative Medicine
03/23/2023
 
 
TXT OSTP Goals for Biotechnology and Biomanufacturing
03/23/2023
 
 
TXT Device Cybersecurity is Top Concern for Shuren
03/23/2023
 
 
TXT Consider Antitrust in Apokyn Generic Case: FTC
03/22/2023
 
 
TXT Complete Response for AbbVie Parkinson’s NDA
03/22/2023
 
 
TXT Registry Set Up for Breast Implant Carcinoma Reports
03/22/2023
 
 
TXT Contradictory Info in P&G Nyquil Filing: FDA
03/22/2023
 
 
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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 DDMAC letters;
  • Related industry news capsules;
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