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FDA-RELATED NEWS
 
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TXT Regener-Eyes Illegally Selling Dry Eye Product
10/12/2022
 
 
TXT FDA Lowers Covid Bivalent Booster Age
10/12/2022
 
 
TXT 17 Observations on Empower Pharmacy FDA-483
10/12/2022
 
 
TXT Rolling NDA Filed for OTC Opioid Overdose
10/12/2022
 
 
TXT Is FDA Relying More on ‘Confirmatory Evidence’?
10/12/2022
 
 
TXT Merck, Moderna Developing Personalized Cancer Vaccine
10/12/2022
 
 
TXT Chinese Firm Recalls ‘Unauthorized’ Covid-19 Tests
10/12/2022
 
 
TXT FDA Launches TAP Pilot
10/11/2022
 
 
TXT Legacy Pharmaceutical CGMP Violations
10/11/2022
 
 
TXT Comment Deadline Extended for LASIK Labeling Guidance
10/11/2022
 
 
TXT FDA Loses Court Case Over Generic Minocin
10/11/2022
 
 
TXT FDA Proposes to Deny Hetlioz sNDA
10/11/2022
 
 
TXT More Quality Issues at Lilly Plant: Reuters
10/11/2022
 
 
TXT CGMP Violations at Mexico’s Eksa Mills
10/11/2022
 
 
TXT FDA Rejects Supernus NDA for Parkinson’s Drug
10/10/2022
 
 
TXT Data Backs Pulmonary Hypertension Drug: Merck
10/10/2022
 
 
TXT scPharmaceuticals Gets Heart Failure Drug Approved
10/10/2022
 
 
TXT FDA Clears Zeiss Medical’s Bipolar Forceps
10/10/2022
 
 
TXT FDA Clears Copan Diagnostics’ Colibrí
10/10/2022
 
 
TXT Miscarriage Management Needed on Mifeprex Label: Petititon
10/07/2022
 
 
TXT Glaxo’s Boostrix OK’d for Unborn in Third Trimester
10/07/2022
 
 
TXT Alnylam Gains Expanded Label for Oxlumo
10/07/2022
 
 
TXT FDA Wants Makena Withdrawn While New Trial Conducted
10/07/2022
 
 
TXT Fresenius Recalls Ivenix Infusion Pump
10/07/2022
 
 
TXT FDA Steps to Harmonize with HHS Common Rule
10/06/2022
 
 
TXT Ways to Improve FAERS Signal Review
10/06/2022
 
 
TXT AATD Consortium Partnership Launched
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 Essure Postmarket Study ‘Inadequate’: FDA
10/06/2022
 
 
TXT Lilly Fast Track for Obesity Drug
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
 
 
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