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FDA-RELATED NEWS
 
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TXT Draft Guidance on Biosimilar Container Closure Design
07/31/2026
 
 
TXT Commentary Questions FDA's Drug Innovation Policies
07/31/2026
 
 
TXT FDA Posts User Fee Rates for FY 2027
07/29/2026
 
 
TXT Reviewers Concerned About Data Supporting Replimune Melanoma BLA
07/28/2026
 
 
TXT PhRMA Urges FDA to Clarify Drug Dose Modeling Guidance
07/28/2026
 
 
TXT FDA Moving to a ‘Shared Services’ and Inspections Approach
07/28/2026
 
 
TXT ‘Controlled Evidence Ecosystem’ Needed: Expert Column
07/28/2026
 
 
TXT FDA Accepts for Review Saol Therapeutics’ SL1009 NDA Resubmission
07/28/2026
 
 
TXT 5 Observations in 17-Page Strides Pharma FDA-483
07/28/2026
 
 
TXT Novo Nordisk Seeks Preliminary Injunction Against Lilly
07/27/2026
 
 
TXT CBER Offers Tips for Cell/Gene Therapy BLA Submissions
07/27/2026
 
 
TXT Reviewers Question Data on Capricor's Duchenne Cardiomyopathy Cell Therapy
07/27/2026
 
 
TXT FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails
07/21/2026
 
 
TXT Novo Nordisk Sues Lilly Over GLP-1 Ads
07/21/2026
 
 
TXT CGMP Issues at India’s Shimoga Chemicals
07/21/2026
 
 
TXT No Informed Consent in Alembic Trial
07/21/2026
 
 
TXT Make Better Use of 505(b)(2) Pathway: Column
07/21/2026
 
 
TXT FDA Reform Requires a ‘Whole-of-System’ Strategy: Editorial
07/21/2026
 
 
TXT FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says
07/20/2026
 
 
TXT Opinion Piece Praises Diamantas' Vision for FDA Modernization
07/20/2026
 
 
TXT China Surpasses U.S. in Novel Cancer Drug Approvals Since 2023: Analysis
07/20/2026
 
 
TXT Fujifilm Diosynth Cited Over NC Plant’s Microbial Contamination Controls
07/17/2026
 
 
TXT Active Drug Shortages Still Trending Up
07/16/2026
 
 
TXT FDA Reevaluating Makary’s Journal Articles, Podium Policies: DeGette
07/16/2026
 
 
TXT Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes
07/16/2026
 
 
TXT Hearing Highlights Concerns Over Biomedical Innovation Growing in China
07/15/2026
 
 
TXT House Hearing Previews Debate Over FDA Modernization, User Fees
07/15/2026
 
 
TXT A ‘New Era of Innovation’ for FDA Public Health Pillars
07/15/2026
 
 
TXT VAI Close Out for HLB Inspection
07/15/2026
 
 
TXT Kennedy Wanted Sentinel, BEST Data: Reuters
07/15/2026
 
 
TXT Pallone Asks GAO to Analyze RIF Impact on User Fees
07/14/2026
 
 
TXT Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust
07/14/2026
 
 
TXT CGMP Issues Found at International Medication Systems
07/14/2026
 
 
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 8 Observations on Fujifilm Diosynth FDA-483
04/29/2026
 
 
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 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 FDA Panel Backs Replimune Melanoma Therapy
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
 
 
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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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