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FDA-RELATED NEWS
 
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TXT Food & Drug Legal Icon Peter Barton Hutt Passes Away at 91
09/03/2026
 
 
TXT AbbVie Announces Positive Etentamig Data in Multiple Myeloma
09/03/2026
 
 
TXT Pediatric Research Policy and Procedure
09/02/2026
 
 
TXT Stakeholder Suggestions to Improve Gene Therapy Draft Guidance
09/02/2026
 
 
TXT CGMP Violations at Fresenius Ogden, UT, Plant
09/01/2026
 
 
TXT CGMP Violations Seen at India’s Reliance Life Sciences
09/01/2026
 
 
TXT Pharmaceutics International CGMP Violations
09/01/2026
 
 
TXT 2 Companies Pause Some CAR T Studies
09/01/2026
 
 
TXT FDA Backs PFAS Used in Medical Devices
09/01/2026
 
 
TXT Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function
09/01/2026
 
 
TXT D.C. Circuit Raises Bar for Generic Drug Exclusivity
08/31/2026
 
 
TXT Courts Rejecting Loper Arguments in Product Liability: Attorney
08/27/2026
 
 
TXT Boston Scientific ENROUTE System Recall is Class 1
08/26/2026
 
 
TXT Do More to Capture Nonprescription Drug Use Info: Meeting
08/26/2026
 
 
TXT Osfamide Shortage Seen
08/26/2026
 
 
TXT Device, Drug Recalls Down, Units Up
08/25/2026
 
 
TXT Create Unified Reference-Anchored Framework for Follow-Ons
08/25/2026
 
 
TXT Scholar Rock Removes Catalent Facility from BLA to Advance Apitegromab
08/21/2026
 
 
TXT Commissioner Pick Faces Potentially Lengthy Senate Confirmation
08/20/2026
 
 
TXT Digital Health Technologies Capture Real-Time Info: Column
08/20/2026
 
 
TXT 4 Observations in Suretec Inspection
08/20/2026
 
 
TXT No Quality Unit Seen in Safrel Pharmaceuticals Inspection
08/20/2026
 
 
TXT FDA Issues Complete Response Letter for Xspray Pharma’s Dasynoc
08/20/2026
 
 
TXT Repeat CGMP Violations at K.C. Pharmaceuticals
08/19/2026
 
 
TXT How Will FDA Regulate ‘Vision Language Models’?
08/18/2026
 
 
TXT 4 API Manufacturing Violations at China’s Tianjin Kilo
08/18/2026
 
 
TXT CGMP Violations Found in Eugia Pharma Inspection
08/18/2026
 
 
TXT Trump Picks Health Policy Adviser Overton as FDA Commissioner Nominee
08/18/2026
 
 
TXT FDA Seeks Injunction Against Steiner Biotechnology
08/13/2026
 
 
TXT PDUFA VIII Commitment Letter Outlines Changes to Drug Review, Manufacturing Oversight
08/13/2026
 
 
TXT Guidance on Risk-Based Approach to Drug Packaging Systems
08/13/2026
 
 
TXT Experts Warn of Edema Risk With Vykat XR as FDA Evaluates Risk
08/13/2026
 
 
TXT Ban Infants’ Tylenol: Children’s Health Defense
08/12/2026
 
 
TXT Use More Advisory Committee Temporary Voting Members: Column
08/12/2026
 
 
TXT FDA Obstacles Lead to Overseas Trials: Survey
08/12/2026
 
 
TXT FDA Guide Updates Procedures for Formal Drug/Biologic Meetings
08/12/2026
 
 
TXT FDA Expedited IND to Lean on Rolling Submissions/Reviews
08/12/2026
 
 
TXT Lilly Files Six Lawsuits Over Illegal Retatrutide Sales
08/12/2026
 
 
TXT New Pathway Sought for Albuterol Inhalation Aerosol Products
08/11/2026
 
 
TXT Moderna Wins Approval for mRNA Flu Vaccine
08/06/2026
 
 
TXT Surge In FDA Drug Warning Letters Shows Structural Problem: Consultant
08/06/2026
 
 
TXT AdvaMed Strongly Backs MDUFA 6 Agreement
08/06/2026
 
 
TXT FDA Accelerated Approval for Replimune Melanoma Therapy
08/06/2026
 
 
TXT Device Regulators Guide on Change Control Plans for Device Software
08/06/2026
 
 
TXT Merck sBLA for Expanded Use of RSV Therapy
08/06/2026
 
 
TXT Reps. Want FDA to Address Estrogen Patch Shortages
08/06/2026
 
 
TXT FDA Outlines IND Pilot to Speed Early Clinical Trials, Counter Overseas Competition
08/05/2026
 
 
TXT Quantitative Medicine Innovation Network RFI
08/05/2026
 
 
TXT FDA, Tonix Align on Lyme Disease Prevention Phase 2 Study
08/05/2026
 
 
TXT Inspection Flags Sterility and Quality Control Concerns at Zydus Lifesciences
08/05/2026
 
 
TXT FDA Approves Takeda’s Orzeyful for Narcolepsy Type 1
08/05/2026
 
 
TXT Arrowhead Acquires Priority Voucher to Speed Plozasiran Expanded Indication
08/04/2026
 
 
TXT Dabur India CGMP Violations
08/04/2026
 
 
TXT Lilly Gets Breakthrough Status for Pancreatic Cancer Therapy
08/03/2026
 
 
TXT Ziltivekimab Misses Endpoint in Cardiovascular Outcomes Trial
07/31/2026
 
 
TXT New FDA Flexibility in Cell and Gene Therapy Approvals
07/30/2026
 
 
TXT FDA Proposed Rule Changes Facility Registration
07/30/2026
 
 
TXT Sen. Johnson Wants Covid Interviews with Former FDAers, Fauci
07/30/2026
 
 
TXT Cerovene Cited for Repeat Manufacturing and Data Integrity Deficiencies
07/30/2026
 
 
TXT Ways to Overcome Cancer Trial Site Activation Bottlenecks: Research
07/30/2026
 
 
TXT 9 Items on Bentley Laboratories FDA-483
07/29/2026
 
 
TXT FDA De Novo OK for CaRi-Heart Coronary Inflammation Technology
07/29/2026
 
 
TXT New Effectiveness Evidence Requirements Analyzed
07/29/2026
 
 
TXT Linemaster Switch QS Violations
07/28/2026
 
 
TXT FDA: VasoCorp Selling Unapproved, Misbranded Drugs
07/28/2026
 
 
TXT FDA Sends Congress FY 2024 Pediatric Device Approval Report
07/28/2026
 
 
TXT Lilly’s Retatrutide Hits Endpoint in 2 Trials
07/23/2026
 
 
TXT 2026 Warning Letter Trends Analyzed by Attorney
07/23/2026
 
 
TXT 4 Observations in Behring German Facility Inspection
07/23/2026
 
 
TXT FDA: PDUFA 7 CMC Commitments Complete
07/23/2026
 
 
TXT Efforts Needed to Improve Health Outcomes, Califf Says
07/23/2026
 
 
TXT HELP Committee Advances Biosimilar Bill
07/23/2026
 
 
TXT FDA Plan Would ‘Fundamentally Reshape’ Drug Ads
07/22/2026
 
 
TXT FDA, Industry Have MDUFA 6 Agreement in Principle
07/22/2026
 
 
TXT FDA Cites Cliantha Research on Data Integrity, Quality Unit
07/22/2026
 
 
TXT Petition Urges FDA to Create Pathway for Brain-Computer Interfaces
07/22/2026
 
 
TXT FDA May Go Months Without Senate-Confirmed Commissioner: Analysis
07/22/2026
 
 
TXT Diamantas Touts FDA Moves to Boost U.S. Jobs
07/22/2026
 
 
TXT Study Finds Compounded GLP-1 Market Remains Strong Despite FDA Crackdown
07/20/2026
 
 
TXT Alvotech EF FDA-483 Released
07/16/2026
 
 
TXT Court Backs FDA, Medtronic in Stimulator Suits
07/16/2026
 
 
TXT 13 Observations in Zhejiang Hushai Inspection
07/16/2026
 
 
TXT Biogen Defends Anti-Tau Alzheimer's Data After Investor Selloff
07/14/2026
 
 
TXT FDA Approves At-Home Dosing of Leqembi for Alzheimer's
07/13/2026
 
 
TXT Proposed Rule to Modernize Drug Manufacturing Registration
07/10/2026
 
 
TXT Agency Sends 3rd Complete Response on Hengrui, Elevar NDA
07/10/2026
 
 
TXT Subcutaneous Sarclisa with On-Body Injector Approved
07/10/2026
 
 
TXT FDA Fast Tracks Arialys’ ART5803
07/09/2026
 
 
TXT White House Looking at 3 Possible FDA Commissioners: Reports
07/09/2026
 
 
TXT FDA Drug, Biologics Centers Continue Workforce Decline
07/09/2026
 
 
TXT Increase in Drug WLs Shows Structural Problem: Analysis
07/09/2026
 
 
TXT Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.
07/09/2026
 
 
TXT Mixed Stakeholder Views on Priority Voucher Pilot
07/08/2026
 
 
TXT Catalent Indiana FDA-483 Out
07/08/2026
 
 
TXT FDA Pauses Release of Complete Response Letters as it Mulls Policy
07/08/2026
 
 
TXT FDA Plans Rule to Require Full Risk Info in Drug Ads
07/07/2026
 
 
TXT LyfeUnit Selling Unapproved Ketamine Products: FDA
07/07/2026
 
 
TXT FDA Moves to Cement Complete Response Letter Transparency Policy
07/07/2026
 
 
TXT Companies Can Use AI to Prepare for Inspections
07/07/2026
 
 
TXT QuVa Pharma Inspection Observations
07/07/2026
 
 
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