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FDA-RELATED NEWS
 
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TXT FDA Restarts Complete Response Letter Postings
07/10/2026
 
 
TXT FDA Inspection Cites SGS North America Contract Laboratory
07/10/2026
 
 
TXT BlephEx 12-Page Warning Letter
07/08/2026
 
 
TXT Restore Former Inspection Processes: Gortler
07/08/2026
 
 
TXT Operation TrialBlazer May Reshape Clinical Development: Ropes & Gray
07/08/2026
 
 
TXT OAI Inspections at U.S. Drug Sites Surpassed India in 2025: Analysis
06/26/2026
 
 
TXT FDA ‘Making Good Progress’ Hiring New Staff: Zeta
06/24/2026
 
 
TXT Administration Weighs White House Aide for FDA Top Post
06/24/2026
 
 
TXT JAMA Publishes Previously Blocked Covid-19 Vaccine Study
06/24/2026
 
 
TXT FDA FY 2027 Appropriation Report Analyzed
06/24/2026
 
 
TXT FDA Details Standardized Approach to Drug Safety Signal Detection
06/24/2026
 
 
TXT FDA Nixes Enforcement Action Against Whoop's Blood Pressure Feature
06/23/2026
 
 
TXT Expand Real-World Evidence Use in Drug Approvals: Article
06/23/2026
 
 
TXT Redact CRLs for Unapproved Applications: Petition
04/22/2026
 
 
TXT Senators Demand HHS Reverse Autism-Related Web Site Changes
03/17/2026
 
 
TXT FDA Enforcement Year in Review
01/27/2026
 
 
TXT Vanda Hetlioz sNDA Not Approvable, FDA Says
01/08/2026
 
 
TXT FDA Warns Apotex Canadian Manufacturing Site
11/05/2025
 
 
TXT FDA Takes Actions to Curb Autism
09/22/2025
 
 
TXT GDUFA Post-Warning Letter Meeting Guidance
06/18/2025
 
 
TXT Can Surprise Foreign Drug Inspections Boost Safety?
06/10/2025
 
 
TXT FDA Policy Head on Major Trump Changes at FDA
05/19/2025
 
 
TXT Vanda Tradipitant Scheduling Order Out
05/01/2025
 
 
TXT Little Trust in New Health Leaders: Poll
04/30/2025
 
 
TXT Hill Staffer Graham Appointed to FDA Policy Office
04/16/2025
 
 
TXT Celltrion’s Humira Biosimilar Now Interchangeable: FDA
04/16/2025
 
 
TXT Marks’ Firing Challenges RFK Jr.’s Fitness for Office
03/31/2025
 
 
TXT DOGE-Targeted FDA Lab to Remain Open
03/05/2025
 
 
TXT FDA Promotes Centralized Statistical Trial Monitoring
12/13/2024
 
 
TXT FDA Sees New Ocaliva Liver Injuries
12/12/2024
 
 
TXT FDA Hasn’t Inspected Factory with Recalls: ProPublica
12/12/2024
 
 
TXT DTC Ad Enforcement to Increase Under Trump: Panel
12/12/2024
 
 
TXT Dr. Reddy’s Hit With Form-483 After API Inspection
03/10/2021
 
 
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 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 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 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 WEBVIEW CLOSED JULY 4TH WEEK
06/26/2026
 
 
TXT Antibody Impurity Guidance Needs Specificity: Comments
06/25/2026
 
 
TXT Stakeholders Comment on AI-Enabled Trial Pilot
06/25/2026
 
 
TXT FDA Cites Pinnacle Biologics for Misleading Photofrin Promo Videos
06/25/2026
 
 
TXT Agency Says Firm Submitted Invalid Data
06/25/2026
 
 
TXT FDA Policymaking May Return to Normalcy: Former FDAers
06/25/2026
 
 
TXT Cotton Introduces Bill Targeting Chinese-Made Medical Devices
06/25/2026
 
 
TXT Drug Quality Assurance Inspections Up in 2025
06/25/2026
 
 
TXT FDA Progressing Toward Replacing Animal Testing :Study
06/25/2026
 
 
TXT JAMA Revisits FDA's Controversial OK of Depression Drug Gepirone
06/24/2026
 
 
TXT Drug Trial Demographic Info Reported
06/24/2026
 
 
TXT Require IDE for Vena’s MicroAngioscope: Petition
06/24/2026
 
 
TXT 4 CGMP Violations in Huons Inspection
06/23/2026
 
 
TXT FDA Leadership Upheaval Yields Uncertainty: Post
06/23/2026
 
 
TXT FDA Bought Unapproved New Drugs on Amazon
06/23/2026
 
 
TXT Gottlieb Praises Clinical Trial Initiative; Calls for FDA Career Leadership
06/23/2026
 
 
TXT Jubilant HollisterStier CGMP Issues
06/23/2026
 
 
TXT Pharmaneek Inspection Form FDA-483 Out
06/23/2026
 
 
TXT HHS Unveils Initiative to Accelerate U.S. Clinical Trials
06/22/2026
 
 
TXT Regenxbio Gets FDA Agreement to Refile Gene Therapy BLA
06/22/2026
 
 
TXT Former FDA Drug Chief Questions Future of Priority Voucher Program
06/22/2026
 
 
TXT FDA Regulatory Pathway Needed for Dementia Vaccine Trials: Opinion
06/19/2026
 
 
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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:
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