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FDA-RELATED NEWS
 
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TXT OMB Approves 5 Information Collections
10/19/2022
 
 
TXT Advisory Panel Rescheduled for Covid Therapy
10/19/2022
 
 
TXT FDA Awards 5 Biosimilars Research Grants
10/19/2022
 
 
TXT Torrent Pharmaceuticals FDA-483
10/19/2022
 
 
TXT ‘Uneven Readiness’ Seen for Supply Chain Law
10/19/2022
 
 
TXT Jail for 2 Women in Clinical Trial Data Case
10/19/2022
 
 
TXT Quality System, Other Violations at Forcemech
10/18/2022
 
 
TXT New FDA Rare Disease Grants, Contracts
10/18/2022
 
 
TXT CDRH Proposes 18 FY 2023 Guidances
10/18/2022
 
 
TXT Too Few Older Adults in Trials: Study
10/18/2022
 
 
TXT Changes Urged in ANDA Amendments Appendix
10/18/2022
 
 
TXT Califf Still Seeking Revamp of Accelerated Approval
10/18/2022
 
 
TXT Multiple Violations at Beijing Xinggu Lvsan
10/18/2022
 
 
TXT Draft Guide on Tissue Agnostic Drug Development
10/17/2022
 
 
TXT Guide on Immune-mediated Adverse Reactions
10/17/2022
 
 
TXT Medtronic Modifies Software for HeartWare Pump Problem
10/17/2022
 
 
TXT Guide on Acute Myeloid Leukemia Therapies
10/17/2022
 
 
TXT Review on Biogen Lou Gehrig’s Drug Extended
10/17/2022
 
 
TXT 2 Inspection Program Guides Revised
10/17/2022
 
 
TXT Guide on ANDA Prior Approval Supplements
10/14/2022
 
 
TXT Ulrich Medical 3D-printed Flux-C Cleared
10/14/2022
 
 
TXT ‘Missed Opportunity’ on FDA Reforms: Ex-Commissioners
10/14/2022
 
 
TXT Travere Expecting 3-month NDA Review Extension
10/14/2022
 
 
TXT Revive Therapeutics Amends Protocol on Covid Therapy
10/14/2022
 
 
TXT CMS Working with FDA on New Device Coverage Rule
10/13/2022
 
 
TXT FDA Revamping NDA/BLA Information Requests
10/13/2022
 
 
TXT Three Charged with Falsifying Clinical Trial Data
10/13/2022
 
 
TXT FDA Publishes ICH E19 Guideline
10/13/2022
 
 
TXT FDA Seeks Covis Info for Makena Hearing
10/13/2022
 
 
TXT GSK Respiratory Syncytial Virus Vaccine ‘Highly Efficacious’
10/13/2022
 
 
TXT FDA Says Adderall is in Shortage
10/13/2022
 
 
TXT CMC Comparability Protocol Guidance
10/13/2022
 
 
TXT Distributed Manufacturing Discussion Paper
10/13/2022
 
 
TXT OPDP Wants to Research Drug Name Interpretation
10/13/2022
 
 
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 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
 
 
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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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