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FDA-RELATED NEWS
 
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TXT Circulating Tumor DNA Use Guidance
11/27/2024
 
 
TXT Patheon Italia FDA-483 Out
11/27/2024
 
 
TXT Guide on Assessing Ovarian Toxicity
11/27/2024
 
 
TXT 8 GDUFA Science and Research Priorities
11/27/2024
 
 
TXT PTC Trial in ALS Patients Misses Endpoint
11/27/2024
 
 
TXT FDA Alert on Skysona Hematologic Malignancies
11/27/2024
 
 
TXT Soleno NDA Review Extended by 3 Months
11/26/2024
 
 
TXT Device Sterilization Enforcement Discretion Guide
11/26/2024
 
 
TXT Let FDA Set AI Postmarket Standards: Califf
11/26/2024
 
 
TXT Multiple Adept Medical Violations Cited
11/26/2024
 
 
TXT CGMP Violations at Italy’s Eurosirel
11/26/2024
 
 
TXT Oncologic Drugs Ovarian Toxicity Guidance
11/26/2024
 
 
TXT Court Tosses Attorney’s Privacy Suit Against FDA
11/26/2024
 
 
TXT Follow-up Testing for Ames-Positive Drugs: Guide
11/26/2024
 
 
TXT Trump Selects Johns Hopkins Makary as FDA Head
11/25/2024
 
 
TXT Device EtO Sterilization Transitional Enforcement Policy
11/25/2024
 
 
TXT Zimmer Biomet Cementless Partial Knee OK’d
11/25/2024
 
 
TXT Cassava Stops Controversial Alzheimer’s Drug Developoment
11/25/2024
 
 
TXT Neurogene Gene Therapy Patient Dies After Dosing
11/22/2024
 
 
TXT Endo Recalls Clonazepam Due to Mislabeling
11/22/2024
 
 
TXT FDA Research Links Montelukast to Mental Issues
11/22/2024
 
 
TXT Jazz Biliary Tract Cancer BLA Approved
11/22/2024
 
 
TXT 2 Orthopedic Non-Spinal Bone Guidances Posted
11/22/2024
 
 
TXT CDRH New Pilot on High-Risk Recalls
11/21/2024
 
 
TXT MXBBB Recalls Umary Hyaluronic Acid Tablets
11/21/2024
 
 
TXT Over 290 OCI Arrests in FY 2023: FDA
11/21/2024
 
 
TXT ‘Burdensome’ Device Assessment Guidance: Post
11/21/2024
 
 
TXT Johns Hopkins Surgeon Eyed for FDA Top Job
11/21/2024
 
 
TXT Need for Device Transparency Seen in Celect Case
11/21/2024
 
 
TXT Draeger Atlan Recall is Class 1
11/20/2024
 
 
TXT Third-Party Review Guidance
11/20/2024
 
 
TXT New DTC Major Statement Standards Become Effective
11/20/2024
 
 
TXT Preserve Covid-19 Vaccine Records: Senator
11/20/2024
 
 
TXT CDER Deputy Throckmorton Retiring in January
11/20/2024
 
 
TXT PCCP Draft Guidance Stakeholder Recommendations
11/20/2024
 
 
TXT Fludarabine Phosphate Labeling Changes OKd
11/20/2024
 
 
TXT FDA Clears Ultromics EchoGo Amyloidosis Device
11/20/2024
 
 
TXT Sage Ending Dalzanemdor Development
11/20/2024
 
 
TXT FDA Warns Unexo Lifesciences Over CGMP
11/19/2024
 
 
TXT FDA Finds CGMP Violations in Originitalia Inspection
11/19/2024
 
 
TXT Put Semaglutide Drugs on DDC Lists: Novo Nordisk
11/19/2024
 
 
TXT CGMP Violations at Silliker Contract Lab
11/19/2024
 
 
TXT Tom’s of Maine CGMP Issues
11/19/2024
 
 
TXT Advisors Asked About Generative AI Regulation
11/19/2024
 
 
TXT Astellas Gets ‘Complete Response’ on Izervay sNDA
11/19/2024
 
 
TXT Stakeholder Comments on Oncology Trial Guidance
11/19/2024
 
 
TXT Panel Input Sought on Andexxa’s Thrombosis Risk
11/19/2024
 
 
TXT GSK Liver Disease Anti-Itch Drug Meets Endpoint
11/19/2024
 
 
TXT Cell/Gene Therapy Guide on Common Questions
11/18/2024
 
 
TXT Aldeyra Dry Eye NDA Accepted for Review
11/18/2024
 
 
TXT BrightHeart AI Review of Heart Ultrasounds Cleared
11/18/2024
 
 
TXT Takeda Slapped with 4-Item FDA-483
11/18/2024
 
 
TXT Martinez Permanently Debarred Over Trial Data
11/18/2024
 
 
TXT GAO Report Urges Key Strategies for FDA Rare Disease Efforts
11/18/2024
 
 
TXT Alert on VasoView Vessel Harvesting Devices
11/15/2024
 
 
TXT Phase 3 Eye Study Terminated After Data Review
11/15/2024
 
 
TXT FDA OKs Syndax Pharm Leukemia Drug
11/15/2024
 
 
TXT RFK Jr. Aims to ‘Free FDA from Corporate Capture’
11/15/2024
 
 
TXT Dupixent Supplemental BLA Filed for Urticaria
11/15/2024
 
 
TXT More Than 1,000 Breakthrough Device Designations
11/14/2024
 
 
TXT FDA Approves PTC Therapeutics’ Kebilidi
11/14/2024
 
 
TXT Medical Device Recalls Up, Drugs Down: Sedgwick
11/14/2024
 
 
TXT SonoMotion De Novo for Stone Clear Ultrasound
11/14/2024
 
 
TXT ‘False or Misleading’ Xeomin Promotion: FDA
11/14/2024
 
 
TXT Innovative Manufacturing Technologies Comments
11/14/2024
 
 
TXT Trump Taps RFK Jr. as HHS Secretary
11/14/2024
 
 
TXT Boston Scientific Recalls Cryoablation Catheters
11/13/2024
 
 
TXT LivaNova Sleep Apnea Device Meets Endpoints
11/13/2024
 
 
TXT FDA Needs Inspection Staff Recruitment Plan: GAO
11/13/2024
 
 
TXT Require Studies for Prednisolone Eye Drops: DifGen
11/13/2024
 
 
TXT Adaptimmune Therapeutics Plan Lete-Cel BLA
11/13/2024
 
 
TXT 7 Observations on U.S. Specialty FDA-483
11/13/2024
 
 
TXT Oligonucleotide-Based Therapeutic Assessment
11/13/2024
 
 
TXT SCOTUS Decisions’ Effect on FDA Analyzed
11/13/2024
 
 
TXT QS Issues at American Contract
11/12/2024
 
 
TXT CGMP Violations in Zhejiang Qimei Records Review
11/12/2024
 
 
TXT House Republicans Want GAO Lab Safety Review
11/12/2024
 
 
TXT FDA Warns Taiwanese, Australian X-ray Firms
11/12/2024
 
 
TXT Complete Response Letter on Ocaliva sNDA
11/12/2024
 
 
TXT Disappointed Califf on Possible Disruption at FDA
11/12/2024
 
 
TXT Lilly Opposes Tirzepatide Bulks List Nomination
11/12/2024
 
 
TXT Clinical Hold on Novavax Vaccines Lifted
11/11/2024
 
 
TXT Safety Issue Prompts Zelnecirnon Termination
11/11/2024
 
 
TXT J&J’s Nipocalimab Gets Breakthrough Status
11/11/2024
 
 
TXT Disappointing Data in Schizophrenia Drug: AbbVie
11/11/2024
 
 
TXT Brookfield Medical Hit with GMP Untitled Letter
11/11/2024
 
 
TXT FDA Clears Vertiwedge Intraosseous Device
11/11/2024
 
 
TXT Group Criticizes FDA Foot Dragging on Phenylephrine
11/08/2024
 
 
TXT Neurotech Review Extension on Retinal Disease BLA
11/08/2024
 
 
TXT Darxalex Faspro sBLA for Smoldering Multiple Myeloma
11/08/2024
 
 
TXT Bayer’s Medrad Centargo CT Injection Cleared
11/08/2024
 
 
TXT Allogene Reports Encouraging CAR-T Therapy Data
11/08/2024
 
 
TXT IRB Violations Seen in FDA-483s
11/07/2024
 
 
TXT Public Citizen Blasts Potential Drug Approval Change
11/07/2024
 
 
TXT FDA Ban on Phenylephrine in Nasal Decongestants
11/07/2024
 
 
TXT Poor Training Found in Lab Inspections
11/07/2024
 
 
TXT FDA Approves J&J Varipulse Platform
11/07/2024
 
 
TXT Sarepta Scraps Next-Gen Duchenne Drug
11/07/2024
 
 
TXT Model-Informed Drug Development Comments
11/07/2024
 
 
TXT Electa Instrument Recalls Biopsy Needle Kits
11/07/2024
 
 
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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:
  • 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