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FDA-RELATED NEWS
 
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TXT Ways to Improve FAERS Signal Review
10/06/2022
 
 
TXT AATD Consortium Partnership Launched
10/06/2022
 
 
TXT FDA Steps to Harmonize with HHS Common Rule
10/06/2022
 
 
TXT Essure Postmarket Study ‘Inadequate’: FDA
10/06/2022
 
 
TXT Lilly Fast Track for Obesity Drug
10/06/2022
 
 
TXT FDA Needs More Postmarket Commitment Authority: Study
10/06/2022
 
 
TXT 2 Final Post-Approval Activity Guidances
10/06/2022
 
 
TXT Roche’s Pathway Test OK’d for Low HER2
10/05/2022
 
 
TXT IR, DRL Guidance
10/05/2022
 
 
TXT Competitive Generic Therapies Guidance
10/05/2022
 
 
TXT Glaxo Lung Cancer Phase 2 Trial Meets Endpoint
10/05/2022
 
 
TXT No Pre-EUA for Eiger Covid Treatment
10/05/2022
 
 
TXT Post-CRL Clarification Teleconference Guidance
10/05/2022
 
 
TXT Reject Novel Liability Theory for Rx Drugs: WLF
10/05/2022
 
 
TXT 4 CBER SOPPs on Application Processing
10/05/2022
 
 
TXT Bayer Reiterates Position on Apotex ANDA
10/05/2022
 
 
TXT Manufacturing Woes Lead to Natpara Discontinuation
10/04/2022
 
 
TXT Rare Disease Endpoint Advancement Pilot
10/04/2022
 
 
TXT Flawless Beauty and Skin Selling Illegal Products: FDA
10/04/2022
 
 
TXT CGMP Violations at Sterling Pharmaceutical
10/04/2022
 
 
TXT U.S. Gov’t Asked to Weigh in on Skinny Label Case
10/04/2022
 
 
TXT Accelerated Approval Transforms Precision Oncology: Study
10/04/2022
 
 
TXT 510(k), De Novo, PMA Review Clock Guidances
10/04/2022
 
 
TXT Guide on ANDA Facility Readiness and Goal Dates
10/03/2022
 
 
TXT Guide on Generic Drug Size and Shapes
10/03/2022
 
 
TXT Lupin Gets Warning Letter After Inspection
10/03/2022
 
 
TXT Increased Covid Risk For Those on Evusheld: FDA
10/03/2022
 
 
TXT FDA Funds Biosimilar Research to Boost Development/Review
10/03/2022
 
 
TXT GE Healthcare Gets AIR Recon Imaging Clearance
10/03/2022
 
 
TXT User Fee Reauthorization Signed Into Law
09/30/2022
 
 
TXT Senate OKs Bill Ending Animal Testing Mandates
09/29/2022
 
 
TXT Medtronic’s Hemostasis Agent Cleared for Upper GI
09/29/2022
 
 
TXT Amylyx Lou Gehrig’s Disease Drug Approved
09/29/2022
 
 
TXT Radiology Display Device Submission Guidance
09/29/2022
 
 
TXT Medical Device Data Systems Guidance
09/29/2022
 
 
TXT FDA in New AMP Heart Failure Program
09/29/2022
 
 
TXT Comments on COA Guidance
09/29/2022
 
 
TXT Mfr. Deficiencies Hamper 1st Cycle ANDA Reviews
09/29/2022
 
 
TXT Eisai/Biogen Claim Lecanemab Trial Success
09/28/2022
 
 
TXT Oncologic Surrogates Rarely Correlate with Survival: Study
09/28/2022
 
 
TXT FDA Mobile Medical App Software Policy
09/28/2022
 
 
TXT FDA, VA Collaborate to Accelerate Device Innovation
09/28/2022
 
 
TXT Comments on Drug Interaction Study Guidance
09/28/2022
 
 
TXT FDA Radiology CADe Device Guidance
09/28/2022
 
 
TXT FDA Safety Notices Can Affect Liability: Analysis
09/28/2022
 
 
TXT Feds Interested in FDA-based False Claims Cases: Attorneys
09/28/2022
 
 
TXT Delta Pharma FDA-483 Released
09/28/2022
 
 
TXT Comments on Fit-For-Purpose Draft Guidance
09/27/2022
 
 
TXT OTC Monograph Submission Format Guidance
09/27/2022
 
 
TXT FDA Changing Covid Test Review Policy
09/27/2022
 
 
TXT Clinical Decision Software Guidance
09/27/2022
 
 
TXT CGMP Deviations at Zhejiang Tianyu Pharmaceutical
09/27/2022
 
 
TXT Tissues Office Renamed Office of Therapeutic Products
09/27/2022
 
 
TXT Value in Leveraging Clinical Pharmacology Principles
09/27/2022
 
 
TXT Generic Drug Safety Labeling Legislation
09/27/2022
 
 
TXT Pediatric Extrapolation is Expanding: Study
09/27/2022
 
 
TXT ‘Clean’ User Fee Bill Added to Continuing Resolution
09/27/2022
 
 
TXT Comments on Remote Assessment Guidance
09/27/2022
 
 
TXT Calcium Carbonate OK for Use in Supplements
09/26/2022
 
 
TXT New Regulatory Paradigm Needed for Device Software: FDA
09/26/2022
 
 
TXT Naloxone Guidance Attempts to Ease Availability
09/22/2022
 
 
TXT Expand RTOR to Cell, Tissue Products: PhRMA
09/22/2022
 
 
TXT Comments on Therapeutic Equivalence Draft Guidance
09/22/2022
 
 
TXT OPDP to Study TV Ad Endorsers
09/22/2022
 
 
TXT User Fee Reauthorization Agreement Reached in Senate
09/22/2022
 
 
TXT Accelerated Approval On- and Off-Ramp Approaches
09/22/2022
 
 
TXT Panel Votes Down Spectrum Lung Cancer Drug
09/22/2022
 
 
TXT DoJ Increasing Corporate Enforcement
09/21/2022
 
 
TXT 5 Observations in Cipla FDA-483
09/21/2022
 
 
TXT OIG Identifies FDA Emergency Use Authorization Issues
09/21/2022
 
 
TXT FDA Approves Pedmark for Cisplatin Ototoxicity
09/21/2022
 
 
TXT FDA Stepping Up Drug Inspections in India
09/20/2022
 
 
TXT Government Not Using Park Doctrine Enough: Study
09/20/2022
 
 
TXT BioLab Sciences Illegally Selling Products: FDA
09/20/2022
 
 
TXT FDA Reviewers Question Spectrum’s Pozenveo
09/20/2022
 
 
TXT Agency Questions Confirmatory Study for Pepaxto
09/20/2022
 
 
TXT Year-One Report on the Generic Drug Cluster
09/20/2022
 
 
TXT Vanda Agrees to Pay Over $11 Million in Off-label Suit
09/19/2022
 
 
TXT FDA Reminds on Endotracheal Tube Obstructions
09/16/2022
 
 
TXT HHS Outlines FDA Projects Under Biotech Initiative
09/16/2022
 
 
TXT Akorn Pays $7.9 Million to Resolve False Claims Suit
09/15/2022
 
 
TXT Top FDA-483, Warning Letter Observations
09/15/2022
 
 
TXT FDA Grants, Denies Catalyst Amifampridine Petition
09/15/2022
 
 
TXT Novartis Wants Restrictions on Entresto ANDAs
09/15/2022
 
 
TXT FDA Challenges Illicit Trade Workshop Attendees
09/15/2022
 
 
TXT Baxter Clearlink Solution Set Recall is Class 1
09/15/2022
 
 
TXT Advisors to Discuss Pulse Oximeter Accuracy
09/15/2022
 
 
TXT Elemental Impurities Guidance
09/15/2022
 
 
TXT FDA Rejects Hearing Aid Standardization
09/14/2022
 
 
TXT FDA Partnership on Rare Neurodegenerative Diseases
09/14/2022
 
 
TXT Bob Temple Gets New Title, Role Remains the Same
09/14/2022
 
 
TXT MAPP on SGEs Representing Sponsors Before FDA
09/14/2022
 
 
TXT Affirm Dismissal of Lexapro Case: WLF
09/14/2022
 
 
TXT 3 Observations on Aurobindo FDA-483
09/14/2022
 
 
TXT Texas Longhorn RX Producing Illegal Drugs: FDA
09/13/2022
 
 
TXT $2 Million FDA Grant to Marker Therapeutics
09/13/2022
 
 
TXT Preserve Access to Compounded Hormones: APC
09/13/2022
 
 
TXT ISCT Criticizes Ruling in Cell, Gene Therapy Case
09/13/2022
 
 
TXT FDA Report on Generic Drug Approval Cost Savings
09/13/2022
 
 
TXT FDA in Pistoia Alliance Working Group
09/13/2022
 
 
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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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