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FDA-RELATED NEWS
 
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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 NEWSROOM CLOSED FOR THE HOLIDAYS
12/19/2025
 
 
TXT FDA Guidance on Bioresearch Monitoring Inspections
12/19/2025
 
 
TXT Is Political Pressure Corrupting New FDA Voucher Program?
12/19/2025
 
 
TXT FDA Tumult Keeps Makary Under Microscope: NYT Article
12/19/2025
 
 
TXT FDA Cites GSK Hungary Vaccine Plant
12/19/2025
 
 
TXT AstraZeneca Pulling Andexxa From Market Due to Safety
12/19/2025
 
 
TXT Cobenfy TV Spot ‘False or Misleading’: FDA
12/18/2025
 
 
TXT UBI FDA-483 Has 5 Observations
12/18/2025
 
 
TXT Lilly’s Oral GLP-1 Maintains Weight Loss After Switch
12/18/2025
 
 
TXT Novo Nordisk Files CagriSema NDA for Weight Loss
12/18/2025
 
 
TXT FDA Sends Warning Letters to Makers of Breast Binders
12/18/2025
 
 
TXT PDUFA Talks Hit Snag on Review Timelines/Transparency
12/18/2025
 
 
TXT Clinical Hold on Lung Cancer Trial After Deaths
12/18/2025
 
 
TXT Congressional Dems Want ‘Drug Deal’ Information
12/18/2025
 
 
TXT Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths
12/17/2025
 
 
TXT Medical Device RWE Guidance
12/17/2025
 
 
TXT Merck Cholesterol, Cancer Drugs Added to Voucher Program
12/17/2025
 
 
TXT FDA Warns Catalent Indiana for CGMP Lapses
12/17/2025
 
 
TXT Change Premarin Prescribing Info to Include Equilin: Petition
12/17/2025
 
 
TXT FDA Agentic AI Deployment Raises Concerns
12/17/2025
 
 
TXT GSK Long-Acting Biologic Approved for Asthma
12/17/2025
 
 
TXT FDA Easing Drug Approval Standards: Column
12/17/2025
 
 
TXT Microvascular Tissue Marketing Unapproved New Drug
12/16/2025
 
 
TXT FDA Commissioner Defends Vaccine Stance, Transparency Push
12/16/2025
 
 
TXT Makary Says ‘No Plans’ for Covid Vaccine Boxed Warning
12/16/2025
 
 
TXT 3D Imaging CGMP and Listing Violations
12/16/2025
 
 
TXT FDA Extends Review Timeline for Aldeyra’s Dry Eye Drug
12/16/2025
 
 
TXT Guide to Increase Female Enrollment in Trials
12/16/2025
 
 
TXT Trump Taps Controversial Figure to Lead Cancer Panel
12/16/2025
 
 
TXT 7 Observations on ProRx FDA-483
12/16/2025
 
 
TXT Sanofi Scraps Tolebrutinib MS Filing after Phase 3 Miss
12/15/2025
 
 
TXT Restrictions on Real-World Evidence Regulatory Reviews Eased
12/15/2025
 
 
TXT 2 Guides Posted on Product Safety Reporting
12/15/2025
 
 
TXT GAO Flags Staffing Gaps and Legal Limits With Device Recalls
12/15/2025
 
 
TXT FDA Awards Priority Voucher for Multiple Myeloma Combo
12/15/2025
 
 
TXT Study Warns Drug Trials are Lacking Diversity
12/12/2025
 
 
TXT FDA, Industry Debate ‘America First’ User Fee Incentive
12/12/2025
 
 
TXT FDA Weighs ‘Black Box’ Warning on Covid Vaccines
12/12/2025
 
 
TXT FDA Gives Expedited Review for Lilly Obesity Pill
12/12/2025
 
 
TXT 2 Observations on Astellas Pharma FDA-483
12/11/2025
 
 
TXT Lilly’s Triple-Agonist Cuts Weight by Nearly 29%
12/11/2025
 
 
TXT Healthcare Opposition to Cybersecurity Reg Change
12/11/2025
 
 
TXT ‘Exceptional Performance’ of TAP Pilot: Report
12/11/2025
 
 
TXT FDA OKs 1st At-Home Stimulator for Depression
12/11/2025
 
 
TXT Medical Device Recall Improvement Act Reintroduced
12/11/2025
 
 
TXT Serina Files Response on Parkinson’s Drug Clinical Hold
12/11/2025
 
 
TXT HCT/P Violations at Ponya Therapeutics
12/10/2025
 
 
TXT FDA Clears Rx Digital Therapeutic for Adult ADHD
12/10/2025
 
 
TXT Positive Results for Roche Giredestrant in Some Breast Cancers
12/10/2025
 
 
TXT FDA Neurological Regulator Joins Musk’s Neuralink
12/10/2025
 
 
TXT DoJ urges High Court Review of ‘Skinny-Label’ Dispute
12/10/2025
 
 
TXT No FDAAA Difference in Time to 1st Postmarket Safety Action: Study
12/10/2025
 
 
TXT WLF Warns on New DTC Ad Rules Violating First Amendment
12/10/2025
 
 
TXT Revoke All mRNA Covid Vaccine BLAs: CHD Petition
12/10/2025
 
 
TXT Prescription to Nonprescription Switch MAPP
12/09/2025
 
 
TXT FDA Raises Approval Standards for CAR-T Cancer Therapies
12/09/2025
 
 
TXT Potential ‘Redefinition of Enforcement Boundaries’: Attorneys
12/09/2025
 
 
TXT CGMP Issues at Seaway Pharma
12/09/2025
 
 
TXT First Approval Under New Priority Voucher Program
12/09/2025
 
 
TXT FDA Qualifies 1st AI Drug Development Tool
12/09/2025
 
 
TXT FDA Issues Promotional Guide for Biosimilars/Reference Biologics
12/09/2025
 
 
TXT FDA Says Looking at Safety of RSV Infant Therapies
12/09/2025
 
 
TXT Envoy Medical QS Violations
12/09/2025
 
 
TXT FDA Broadens Covid Vaccine Probe to Include Adult Deaths
12/09/2025
 
 
TXT Experts Call for Overhaul of FDA ‘Revolving Door’ Rules
12/09/2025
 
 
TXT BioNTech, OncoC4 See Good Survival Data for Lung Cancer Drug
12/08/2025
 
 
TXT FDA Delays Decision on Agios’ Mitapivat sNDA for Thalassemia
12/08/2025
 
 
TXT House Dems Seek Answers on FDA Vaccine Memo
12/08/2025
 
 
TXT Petition Urges FDA to Overhaul Biosimilar Approval Rules
12/08/2025
 
 
TXT FDA Delays Safety Review of Abortion Pill Mifepristone
12/08/2025
 
 
TXT Praxis Epilepsy Drug Study Stopped for Positive Efficacy
12/05/2025
 
 
TXT FDA 483 Cites Apotex Over Sterility, Data Integrity Failures
12/05/2025
 
 
TXT Panel Votes to End Newborn Hepatitis B Shot Recommendation
12/05/2025
 
 
TXT Device Compliance Official Flags Quality Gaps, Rising Enforcement
12/05/2025
 
 
TXT Medical Device eCopy Submission Guidance
12/04/2025
 
 
TXT FDA, CMS Launching Tempo Pilot
12/04/2025
 
 
TXT User Fees Could Incentivize U.S. Drug Development
12/04/2025
 
 
TXT Quarter 3 Drug and Device Recalled Units Higher: Sedgwick Index
12/04/2025
 
 
TXT Prasad Defends Vaccine Policy Shift: Report
12/04/2025
 
 
TXT CDER Compliance Chief Details Compliance Shifts
12/04/2025
 
 
TXT Biden Admin Buried Covid Myocarditis Data: Makary
12/04/2025
 
 
TXT Bayesian Statistical Analysis Demonstration Project
12/04/2025
 
 
TXT CBER Inspections Challenged by Lack of Facility Readiness
12/04/2025
 
 
TXT Clinical Hold Lifted on Vanda’s Motion Sickness Studies
12/04/2025
 
 
TXT Political Interference Prompted Pazdur Retirement: Peter Pitts
12/03/2025
 
 
TXT 26 Rare Disease Drug Approvals in 2024: ARC Report
12/03/2025
 
 
TXT American Hospital Association AI Policy Ideas
12/03/2025
 
 
TXT FDA Blocks Lawmakers from Attending Cancer Drug Meeting
12/03/2025
 
 
TXT FDA Grants Full Approval to Lilly’s Jaypirca
12/03/2025
 
 
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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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  • Summaries of DDMAC letters;
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