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 9 10 11 12 13 14 15 16 17 18 19 20 Next >>
 
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
 
 
TXT Animal Drug Regulations Amended
12/06/2023
 
 
TXT Industry Concerns with Predicate Device Guide
12/06/2023
 
 
TXT Review Extended on Sinus Drug
12/06/2023
 
 
TXT Oncology Center Pact on Real-world Evidence
12/05/2023
 
 
TXT Belmont Eyecare Selling Unapproved Eye Drops: FDA
12/05/2023
 
 
TXT MONARCH 3 Results Show Verzenio Success: Lilly
12/05/2023
 
 
TXT How FDA ‘One-stop’ PJOs Help Combo Industry
12/05/2023
 
 
TXT No Safety Issues in Biosimilar Switches: CDER Research
12/05/2023
 
 
TXT Pentagon Hits FDA on Generic Testing
12/05/2023
 
 
TXT FDA Releases Novartis Untitled Letter on GMPs
12/05/2023
 
 
TXT ABK Biomedical Gets Breakthrough Status
12/05/2023
 
 
TXT FDA Urges ClinicalTrials.gov Compliance
12/04/2023
 
 
TXT Lilly’s Jaypirca Gains OK in Leukemia/Lymphoma
12/04/2023
 
 
TXT Pressing Need for Alternative Inspections: Researchers
12/04/2023
 
 
TXT J&J Breakthrough Status on Bladder Cancer Drug
12/04/2023
 
 
TXT Lawmakers Press Califf on OTC Decongestant
12/04/2023
 
 
TXT West Pharma Vial2Bag Admixture Device Cleared
12/04/2023
 
 
TXT CDER Cleaning House on Dormant Petitions
12/01/2023
 
 
TXT Eitan Medical Recall Infusion Pumps
12/01/2023
 
 
TXT Info Collection Extension on Orphan Drugs
12/01/2023
 
 
TXT Twice-Daily Weight Loss Drug Stalls: Pfizer
12/01/2023
 
 
TXT Epcoritamab Breakthrough Status in Follicular Lymphoma
12/01/2023
 
 
TXT BD Recalls Pumps Over Syringe Incompatibility
12/01/2023
 
 
TXT FDA Checking Chinese Syringe Safety
11/30/2023
 
 
TXT Chief Scientist Tapped as Woodcock Replacement
11/30/2023
 
 
TXT More Novo Nordisk Semaglutide Legal Actions
11/30/2023
 
 
TXT AbbVie Seeks Accelerated OK for Lung Cancer Drug
11/30/2023
 
 
TXT UCB on Pregnancy Safety Studies
11/30/2023
 
 
TXT FDA Clears GE Critical Care Suite 2.1
11/30/2023
 
 
TXT FDA Fast Track for eFFECTOR’s Zotatifin
11/30/2023
 
 
TXT AdvaMed Comments on Electronic Submission Guide
11/29/2023
 
 
TXT Concerns About FDA QMM Program
11/29/2023
 
 
TXT Durbin, Grassley Push Drug Ad Transparency Bill
11/29/2023
 
 
TXT FDA Opens Drug Supply Chain Security Act Portal
11/29/2023
 
 
TXT FDA Denies Apixaban ANDA Petition for Safety
11/29/2023
 
 
TXT SCA Pharma Issued 10-Item FDA-483
11/29/2023
 
 
TXT Karuna NDA for Schizophrenia Accepted by FDA
11/29/2023
 
 
TXT Praise for Graft-Versus-Host Drug Guidance
11/29/2023
 
 
TXT FDA Studies Nasal Spray Distribution
11/29/2023
 
 
TXT FDA Still Evaluating Left Atrial Occlusion Implants
11/29/2023
 
 
TXT New Theories of False Claims Act Liability
11/29/2023
 
 
TXT Regenerative Medicine Consensus Standards Guide
11/28/2023
 
 
TXT ‘Similar’ Intas CGMP Violations
11/28/2023
 
 
TXT Korsuva Regulatory Review Period
11/28/2023
 
 
TXT Cosela Regulatory Review Period
11/28/2023
 
 
TXT Serious Reaction to Some Anti-Seizure Meds: FDA
11/28/2023
 
 
TXT Acelyrin Auditing Izokibep Trial Issues
11/28/2023
 
 
TXT Dr. Berne’s Selling Unapproved, Adulterated Eye Drops
11/28/2023
 
 
TXT Malignancy Events with CAR T-Cell Therapies: FDA
11/28/2023
 
 
TXT FDA Warns on Overheating Philips CPAP Devices
11/28/2023
 
 
TXT Biden to use Defense Production Act on Shortages
11/28/2023
 
 
TXT ‘Mixed Reality Device’ CGMP Inspection Success
11/28/2023
 
 
TXT Aldeyra Complete Response on Dry Eye NDA
11/27/2023
 
 
TXT Novartis Recalls 2 Sandimmune Lots
11/27/2023
 
 
TXT FDA Withdraws From Device Harmonization Group
11/27/2023
 
 
TXT Priority Review for Abeona Therapeutics BLA
11/27/2023
 
 
TXT Entrada Therapeutics’ DMD Drug Remains on Hold
11/22/2023
 
 
TXT Covid-19 Treatment, Prevention Products Guidance
11/22/2023
 
 
TXT Guide on GLP Study Translation
11/22/2023
 
 
TXT FDA Declines to Ban Some Music in DTC Ads
11/22/2023
 
 
TXT Masimo Medical Watch Cleared by FDA
11/22/2023
 
 
TXT VAERS Has ‘A Proven Track Record’: FDA/CDC
11/22/2023
 
 
TXT SCOTUS Should Hear Mifepristone Appeal: FDA
11/22/2023
 
 
TXT ‘Objectionable Conditions’ in 2 Clinical Trials
11/21/2023
 
 
TXT Do Postmarket Studies Need Public Funds?: Califf
11/21/2023
 
 
TXT Senators Want Animal Testing Info
11/21/2023
 
 
TXT Chinese National Indicted Over Illegal Devices
11/21/2023
 
 
<< Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  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