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FDA-RELATED NEWS
 
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TXT FDA Sets Acceptable NITMA Level for Ritonavir Products
10/29/2024
 
 
TXT Abeona Refiles BLA for Gene Therapy
10/29/2024
 
 
TXT GE Healthcare EVair Recall Actions No Longer Apply: FDA
10/29/2024
 
 
TXT Protega Abuse-Deterrent Oxycodone Approved
10/29/2024
 
 
TXT Canadian Drug Imports Won’t Help U.S.: Study
10/29/2024
 
 
TXT Trump as President May Tap RFK for FDA Head
10/29/2024
 
 
TXT FDA Won’t Require Qsymia CV Outcome Trial
10/29/2024
 
 
TXT PharmaTher Complete Response Letter on Ketamine
10/28/2024
 
 
TXT De Novo Authorization for Dexter Surgical Robot
10/28/2024
 
 
TXT House GOPs Demand Clinical Data on Puberty Blockers
10/28/2024
 
 
TXT Info Collection on Antimicrobial Animal Drug Sales
10/28/2024
 
 
TXT Broader FDA Interpretations Needed for Review Vouchers: Hill
10/28/2024
 
 
TXT FDA Sued Over Drug Compounding Restrictions
10/28/2024
 
 
TXT Medtronic’s Affera Mapping/Abalation Device Approved
10/25/2024
 
 
TXT Kinova Recalls Wheelchair Robotic Arm
10/25/2024
 
 
TXT Iterum Therapeutics’ Antibiotic OK’d for UTIs
10/25/2024
 
 
TXT Orphan Status for Sickle Cell Disease Drug
10/25/2024
 
 
TXT Support for Biosimilar Product Class Guidances
10/24/2024
 
 
TXT Panel To Discuss 503A Bulk Drug Additions
10/24/2024
 
 
TXT Intellia Reports Positive Data on Gene Therapy
10/24/2024
 
 
TXT Probe Leqembi, Kisunla Trials: Public Citizen
10/24/2024
 
 
TXT Baxter Class 1 Recall of Life2000 Ventilator
10/24/2024
 
 
TXT Researchers Find Alzheimer’s Potential in Semaglutide
10/24/2024
 
 
TXT ASHP Sees 277 Active Drug Shortages
10/24/2024
 
 
TXT Safety Alert on Regener-Eyes Eye Drops
10/24/2024
 
 
TXT FDA to Study Adherence and Patient Preference in Ads
10/23/2024
 
 
TXT AI Forcing FDA to ‘Rethink Everything’: Califf
10/23/2024
 
 
TXT Alto Neuro Depression Study Fails
10/23/2024
 
 
TXT Pinnacle Making Illegal Amniotic Products: FDA
10/23/2024
 
 
TXT Add Semaglutide to DDC Lists: Novo Nordisk
10/23/2024
 
 
TXT FDA Approves Expanded Abrysvo Indication
10/23/2024
 
 
TXT CA Man Pleads Guilty to Selling Unapproved Drugs
10/23/2024
 
 
TXT U.P. Oncolytics Gets Orphan Status for Glioma Therapy
10/23/2024
 
 
TXT Syndax Leukemia Review Extended by FDA
07/29/2024
 
 
TXT NEWSROOM CLOSED FOR THE HOLIDAYS
12/18/2023
 
 
TXT FDA OKs Merck Kidney Cancer Drug
12/17/2023
 
 
TXT FDA OKs Glaukos Intraocular Pressure Drug Implant
12/17/2023
 
 
TXT 2 Imbruvica Accelerated Approvals Withdrawn
12/17/2023
 
 
TXT DTC Survey Examines Quantitative Claims
12/17/2023
 
 
TXT FDA Updates Breast Implant Safety Info
12/17/2023
 
 
TXT Guide on Priority Zoonotic Animal Drugs
12/17/2023
 
 
TXT Moderna Inspection Cites GMP Issues: Report
12/17/2023
 
 
TXT FDA Warns Makers of Illegal Animal Antimicrobials
12/14/2023
 
 
TXT FDA in 3 More Collaborative Communities
12/14/2023
 
 
TXT House Committee Threatens FDA Subpoena
12/14/2023
 
 
TXT FDA ‘Doing Little’ on Social Media Drug Claims: Report
12/14/2023
 
 
TXT Pharmasol Permanent Injunction Approved
12/14/2023
 
 
TXT Clinical Hold on 3 CARsgen CAR T-cell Therapies
12/14/2023
 
 
TXT Stakeholder Technical Issues with Ophthalmic Guide
12/14/2023
 
 
TXT FDA Approves Neuroblastoma Drug
12/14/2023
 
 
TXT Update GAO Device Recall Oversight Report: Senators
12/13/2023
 
 
TXT Novid Distributing Unapproved, Misbranded Drug: FDA
12/13/2023
 
 
TXT Guide on Advanced Manufacturing Tech
12/13/2023
 
 
TXT Regulatory Affairs, Foods Program Under Review
12/13/2023
 
 
TXT HELP Committee OKs EFFECTIVE Opioid Bill
12/13/2023
 
 
TXT GOP Senators Urge Increase in Foreign Inspections
12/13/2023
 
 
TXT Amgen Files Priority BLA for Lung Cancer
12/13/2023
 
 
TXT AdvaMed Faults FDA on ‘Safety’ 510(k) Guidances
12/13/2023
 
 
TXT Supreme Court Agrees to Hear Mifepristone Case
12/13/2023
 
 
TXT New Genetic Metabolic Disease Treatment A/C
12/12/2023
 
 
TXT Strengthen Botox Safety Warning: Public Citizen
12/12/2023
 
 
TXT Advanced Manufacturing Technologies Guidance
12/12/2023
 
 
TXT Dolor Tech Settles Over Migraine Device
12/12/2023
 
 
TXT Peptide Clinical Pharmacology Guidance
12/12/2023
 
 
TXT Risk-Based Approach to Therapeutic Protein DDI
12/12/2023
 
 
TXT CDISC Study Tabulation Model Version 3.4
12/12/2023
 
 
TXT FDA May Not be Ready for LDT Rule: Attorney
12/12/2023
 
 
TXT Oncology Drug Dose Optimization Often Deferred: Analysis
12/12/2023
 
 
TXT First Psychedelic NDA Filing Claimed for PTSD Therapy
12/12/2023
 
 
TXT Trump Aligned Group Sues FDA on Ivermectin
12/11/2023
 
 
TXT Guide on DTC Quantitative Efficacy/Risk Info
12/11/2023
 
 
TXT Device CEO Pleads Guilty in Covid Test Scheme
12/11/2023
 
 
TXT FDA Requiring Less Burdensome Isotretinoin REMS
12/11/2023
 
 
TXT NDA Resubmission on Hypoparathyroidism Accepted
12/11/2023
 
 
TXT PETA Letter Hits at FDA Lab Animal 'Cruelty'
12/11/2023
 
 
TXT Pfizer BLA for Hemophilia Accepted for Review
12/11/2023
 
 
TXT First Sickel Cell Gene Therapies Approved
12/08/2023
 
 
TXT Novartis Reports Risk Reduction Kisqali Data
12/08/2023
 
 
TXT Guide on Drug Supply Chain Security
12/08/2023
 
 
TXT Getinge Recalls CardioHelp Emergency Drive
12/08/2023
 
 
TXT Info Collection on OTC Drugs
12/08/2023
 
 
TXT Cardinal Health Recalls Procedure Kits
12/08/2023
 
 
TXT Section 503B Compounding Enforcement Discretion
12/07/2023
 
 
TXT FDA Clears BD ‘Novel’ Blood Sampler
12/07/2023
 
 
TXT Bill to Establish HHS Generic Drug Manufacturer
12/07/2023
 
 
TXT Alpha Cognition NDA for Alzheimer’s Filed
12/07/2023
 
 
TXT Positive Phase 1/2 Linvoseltamab Results to FDA
12/07/2023
 
 
TXT Pediatric Drug Development Bill Introduced
12/07/2023
 
 
TXT Action Against BPI Methylene Blue Injection Asked
12/07/2023
 
 
TXT Restrict ANDAs for Generic Xipere: Bausch & Lomb
12/07/2023
 
 
TXT Merck Halts Keytruda Lung Cancer Trial
12/07/2023
 
 
TXT Pro Publica Slams FDA on Respirator Recall
12/07/2023
 
 
TXT FDA Sets Bulk Substance Compounding Policy
12/06/2023
 
 
TXT FDA Grants, Denies Provepharm ProvayBlue Petition
12/06/2023
 
 
TXT Novartis’ Fabhalta for PNH Approved
12/06/2023
 
 
TXT Probe FDA ‘Cozy Relationship’ with Pharma: Rep. Harris
12/06/2023
 
 
TXT Restrict ANDAs for Generic Zoryve: Arcutis
12/06/2023
 
 
TXT eSTAR e-Submissions Open for PMAs
12/06/2023
 
 
TXT CBER Helping to Speed Gene Therapies: Marks
12/06/2023
 
 
TXT Opdivo sBLA for Bladder Cancer
12/06/2023
 
 
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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;
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