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FDA-RELATED NEWS
 
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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 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 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 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
 
 
TXT FDA Cites Lundbeck Over Vyepti Promotional Claims
07/07/2026
 
 
TXT MDUFA Performance Goals, Procedures for 2028-2032
07/07/2026
 
 
TXT Former CDC Official Alleges Political Interference In Vaccine Policy
07/06/2026
 
 
TXT Insufficient Data on 7 Peptides for Potential Compounding Use: FDA
07/06/2026
 
 
TXT FDA Sued Over Rejection of Supplement Ad Claims
07/06/2026
 
 
TXT Blood Donor Screening in an Ebola Outbreak
07/06/2026
 
 
TXT Repeat CGMP Violations Seen in Excelvision Inspection
07/06/2026
 
 
TXT Genzyme Ireland Inspection Documents CGMP Issue
07/06/2026
 
 
TXT Abiomed Impella Heart Pump Recall is Class 1
07/06/2026
 
 
TXT Insulet Omnipod Pod Recall is Class 1: FDA
07/06/2026
 
 
TXT FDA Selects 7 PreCheck Pilot Participants
07/06/2026
 
 
TXT Next-Generation Sequencing Data Submission Guidance
07/06/2026
 
 
TXT FDA OKs Blood Cancer Drug Tregzi
07/06/2026
 
 
TXT CGMP Issues at India’s Wizcure Pharmaa
07/06/2026
 
 
TXT Chinese Drug Firm Refuses FDA Record Request
07/06/2026
 
 
TXT CBER SOPP on Implementing, Managing REMS
07/06/2026
 
 
TXT FDA Novel Drug Approvals Remain Steady in 2026 First Half
07/06/2026
 
 
TXT ‘Complete Response’ on Liver Imaging Agent
07/06/2026
 
 
TXT BMC Medical Selling Adulterated, Misbranded CPAPs: FDA
07/06/2026
 
 
TXT FDA OKs Casgevy for Younger Children
07/06/2026
 
 
TXT Quality System, Other Violations at 3B Medical
07/06/2026
 
 
TXT FDA Approves BESREMi Pen for Polycythemia Vera
07/06/2026
 
 
TXT Dr. Reddy's Gets 7-Item FDA Form 483 After Biologics Inspection
06/26/2026
 
 
TXT Lantheus Gets ‘Complete Response’ Letter for Tumor Imaging Agent
06/26/2026
 
 
TXT Report: Three Finalists Emerge in Next Commissioner Search
06/26/2026
 
 
TXT FDA Declines to Approve Sobi Gout Therapy
06/26/2026
 
 
TXT EC Opens Antitrust Probe into Sanofi's Flu Vaccine Marketing
06/26/2026
 
 
TXT FDA WEBVIEW CLOSED JULY 4TH WEEK
06/26/2026
 
 
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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:
  • The latest agency policy developments, often before they're officially announced;
  • Major news insights, follow-ups and reactions in each product area;
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  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
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