FDA Webview Site FDA Review Site FDA Updater Site
header.gif
Username:
Password:
 

human drugs
animal drugs
biologics
eirs 483s
medical devices
marketing
email
search our site
  
FDA-RELATED NEWS
 
<< Prev  1 2 3 4 5 6 7 8 Next >>
 
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TXT Comments on Fit-For-Purpose Draft Guidance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TXT Comments on Therapeutic Equivalence Draft Guidance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
 
 
TXT User Fee Reauthorization Talks Continue
09/13/2022
 
 
TXT FDA Denies Petition on Colonoscopy Preparation
09/12/2022
 
 
TXT FDA Approves BMS Plaque Psoriasis Drug
09/12/2022
 
 
TXT Biomarin Reports Leukemia in Patient on Gene Therapy
09/12/2022
 
 
TXT Boston Imaging V7 Ultrasound Cleared
09/09/2022
 
 
TXT FDA Taps PATH’s Kaslow as Vaccine Chief
09/09/2022
 
 
TXT Pfizer NDA for Alopecia Drug Accepted for Review
09/09/2022
 
 
TXT RWD, RWE Submission Guidance
09/08/2022
 
 
TXT FDA Denies 2014 LASIK Petition
09/08/2022
 
 
TXT UCS Surveying State of Science Under Biden
09/08/2022
 
 
TXT FDA Breast Implant Cancer Alert
09/08/2022
 
 
TXT FDA Emergency Monkeypox Test Guidance
09/08/2022
 
 
TXT Panacea Biotec Inspection is OAI
09/08/2022
 
 
TXT Safety Alert on Abbott’s MitraClip Delivery Systems
09/08/2022
 
 
TXT Nonprescription Drug Label Guidance
09/08/2022
 
 
TXT 7 Observations in Korea’s Hugel FDA-483
09/07/2022
 
 
TXT Pharmacology Pediatric Studies Guidance
09/07/2022
 
 
TXT CDER, CBER Accept 1st ISTAND Submission
09/07/2022
 
 
TXT Stakeholders Want Changes to Supply Chain Guidance
09/07/2022
 
 
TXT Pacira Seeking Expanded Label on Exparel
09/07/2022
 
 
TXT FDA Lifts Hold on Sarepta Duchenne Drug Trial
09/06/2022
 
 
TXT Leaf of Life Marketing Illegal New Drugs: FDA
09/06/2022
 
 
TXT Boston Scientific’s Watchman Gets Revised Label
09/06/2022
 
 
TXT CDER Working to Optimize Drug Absorption
09/06/2022
 
 
TXT FDA Denies Most of Salix Xifaxin Petition
09/06/2022
 
 
TXT Bayer Paying $40 Million to Settle 2 Whistleblower Suits
09/06/2022
 
 
TXT Advancing Regulatory Science at FDA 2022 Report
09/06/2022
 
 
TXT FDA Approves Fresenius Kabi Biosimilar
09/06/2022
 
 
TXT FDA Approves Boehringer Pustular Psoriasis Drug
09/02/2022
 
 
TXT Imfinzi Approved for Biliary Tract Cancer
09/02/2022
 
 
TXT FDA Observations from 3 Biocon Biologics Inspections
09/01/2022
 
 
<< Prev  1 2 3 4 5 6 7 8  Next >>
 
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:
  • The latest agency policy developments, often before they're officially announced;
  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving