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FDA-RELATED NEWS
 
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TXT FDA Hasn’t Inspected Factory with Recalls: ProPublica
12/12/2024
 
 
TXT Contract Lab Valisure Relinquishes its Testing Prowess
12/06/2022
 
 
TXT Ranitidine Products May Return to Market: FDA
09/01/2021
 
 
TXT Dr. Reddy’s Hit With Form-483 After API Inspection
03/10/2021
 
 
TXT FDA Update on Ranitidine Contaminant Testing
10/02/2019
 
 
TXT Dr. Reddy’s Duvvada Facility Cited by FDA Again
03/09/2017
 
 
TXT FDA Releases Dr. Reddy’s Warning Letter
11/24/2015
 
 
TXT Lilly Once-Weekly Insulin Injection Approved
09/24/2026
 
 
TXT Senate Urged to Question Overton on FDA's Scientific Decision-Making
09/22/2026
 
 
TXT Insmed sNDA Gets Priority Review for Arikayce Full Approval
09/21/2026
 
 
TXT FDA Seeks Advisory Panel Input on Galleri Cancer Screening Test
09/21/2026
 
 
TXT Reg Update on Non-Animal Testing Methods in Drug Development
09/21/2026
 
 
TXT Stronger FDA Oversight of Third-Party Device Reviewers Needed: GAO
09/21/2026
 
 
TXT FDA EDDO Control Strategy Guidance Analyzed
09/18/2026
 
 
TXT FDA Approves Lilly Combo for Metastatic Breast Cancer
09/18/2026
 
 
TXT Prepare for Enhanced FDA/SEC Oversight: Sidley
09/16/2026
 
 
TXT FDA Must Correct on Rare Diseases, Not Overcorrect: Column
09/16/2026
 
 
TXT Rescind Filing of 2 Zydus Applications: Gilead
09/16/2026
 
 
TXT Sen. Warren Continues to Push for TrumpRx Contracts
09/16/2026
 
 
TXT Bill to Make Pediatric Rare Disease Voucher Permanent
09/15/2026
 
 
TXT Priority Review for Roche Enspryng sBLA
09/10/2026
 
 
TXT 3 Observations on XeCare FDA-483
09/10/2026
 
 
TXT Bill to Update FDA Drug Preclusion Rules
09/10/2026
 
 
TXT Reduced Application Fees Not Sufficient Incentive: Column
09/10/2026
 
 
TXT Breakthrough Therapy Designation for UCB’s Cimzia
09/09/2026
 
 
TXT Bioresearch Monitoring Violations Found
09/08/2026
 
 
TXT Repeat Fenwal International CGMP Issues Cited
09/08/2026
 
 
TXT FDA Planning Pregnancy Exposure Registry Study
09/08/2026
 
 
TXT AbbVie Announces Positive Etentamig Data in Multiple Myeloma
09/03/2026
 
 
TXT FDA Strengthening Good Clinical Practice Oversight
09/03/2026
 
 
TXT FDA Wants Botanical Drug Development Input
09/03/2026
 
 
TXT Study Connection Between Foreign Drug Manufacturing and Recalls
09/03/2026
 
 
TXT Prevention Is the Best Counter to CRL Risk: Blog Post
09/03/2026
 
 
TXT Food & Drug Legal Icon Peter Barton Hutt Passes Away at 91
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 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 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 Repeat CGMP Violations at K.C. Pharmaceuticals
08/19/2026
 
 
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 How Will FDA Regulate ‘Vision Language Models’?
08/18/2026
 
 
TXT 4 API Manufacturing Violations at China’s Tianjin Kilo
08/18/2026
 
 
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 FDA Seeks Injunction Against Steiner Biotechnology
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 Reps. Want FDA to Address Estrogen Patch Shortages
08/06/2026
 
 
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 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 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 New FDA Flexibility in Cell and Gene Therapy Approvals
07/30/2026
 
 
TXT FDA Proposed Rule Changes Facility Registration
07/30/2026
 
 
TXT New Effectiveness Evidence Requirements Analyzed
07/29/2026
 
 
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 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
 
 
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