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FDA-RELATED NEWS
 
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TXT Guide on Reporting Animal Drug Shortages
05/15/2023
 
 
TXT Orphan Status for Pyxis Pancreatic Cancer Therapy
05/12/2023
 
 
TXT Cordis Class 1 Recall of Angioguard System
05/12/2023
 
 
TXT Congress Urges More FDA Attention to Rare Diseases
05/12/2023
 
 
TXT FDA Encourages Voluntary Device Shortage Notices
05/12/2023
 
 
TXT Panel Backs Epinephrine Nasal Spray
05/12/2023
 
 
TXT FDA Eases Blood Donor HIV Recommendations
05/11/2023
 
 
TXT Cook Tracheostomy Introducer Recall is Class 1
05/11/2023
 
 
TXT FDA OKs Rexulti for Alzheimer’s Agitation
05/11/2023
 
 
TXT More Groups, Experts Back KEI Ad Music Petition
05/11/2023
 
 
TXT FDA Planning for Future Public Health Issues
05/11/2023
 
 
TXT Sibel Health Infant Monitor Cleared
05/11/2023
 
 
TXT Complete Response on Bladder Cancer BLA
05/11/2023
 
 
TXT PhRMA on FDA Negative Controls Workshop
05/11/2023
 
 
TXT CRN Asks FDA to Reconsider Drug Preclusion
05/11/2023
 
 
TXT Abbott MRI Labeling OK’d for Spinal Stimulator
05/11/2023
 
 
TXT Study Data Technical Conformance Guide
05/11/2023
 
 
TXT Stakeholder Ideas on FDA Electronic System Draft
05/11/2023
 
 
TXT FDA Wants Updated Labeling on Some Stimulants
05/11/2023
 
 
TXT Panel to Discuss Pediatric Oncology Dose Optimization
05/10/2023
 
 
TXT CDER Publishes AI/ML Discussion Paper
05/10/2023
 
 
TXT Reviewers Question Sarepta DMD Drug
05/10/2023
 
 
TXT Bill Would Force Drug Research Cost Disclosure
05/10/2023
 
 
TXT FDA Clears Renuvion Handpiece
05/10/2023
 
 
TXT Panel Unanimously Backs OTC Contraceptive Pill
05/10/2023
 
 
TXT Glycol Testing Guidance
05/09/2023
 
 
TXT CGMP Violations in Premier Nutra Pharma Inspection
05/09/2023
 
 
TXT Court Backs FDA in Somatuline Depot Case
05/09/2023
 
 
TXT FDA Clears Cumulus EEG Headset
05/09/2023
 
 
TXT AI/ML Predetermined Change Control Plan Guidance
05/09/2023
 
 
TXT FDA Reviewers Question ARS-1 Development Program
05/09/2023
 
 
TXT Clinical Hold Lifted on Diarrhea Trials
05/08/2023
 
 
TXT Singlera ‘Breakthrough’ on Pancreatic Cancer Assay
05/08/2023
 
 
TXT 2-Day Workshop on Generic Research Iniitiatives
05/08/2023
 
 
TXT Samsung Irregular Heart Monitor on Watch Cleared
05/08/2023
 
 
TXT De Novo Marketing of 2 Covid Serology Tests
05/08/2023
 
 
TXT Califf Warns of Regulation of Large Language Models
05/08/2023
 
 
TXT FDA Releases Sun Non-compliance Letter
05/08/2023
 
 
TXT New Web Page on Antimicrobial Susceptibility Tests
05/05/2023
 
 
TXT Fibrogen Misses Endpoint in Roxadustat Anemia Trial
05/05/2023
 
 
TXT FDA Issues Ajinomoto Bio-Pharma 3-item 483
05/05/2023
 
 
TXT PhRMA, Others Petition Against Drug Importation
05/05/2023
 
 
TXT Actual Use Study Flagged in OTC Birth Control NDA
05/05/2023
 
 
TXT Levitra Not Withdrawn Due to Safety/Efficacy
05/04/2023
 
 
TXT Guide on Decentralized Clinical Trials
05/04/2023
 
 
TXT Reject Rexulti Alzheimer’s sNDA: Public Citizen
05/04/2023
 
 
TXT Name NIH in Drug Patent Applications: GAO
05/04/2023
 
 
TXT Xortx to Pursue Accelerated Approval for Xorlo
05/04/2023
 
 
TXT Device Regulatory Science Tool Catalog Update
05/04/2023
 
 
TXT Califf Recommends FDA Reforms for Pandemic Bill
05/04/2023
 
 
TXT FDA Novo Nordisk Concizumab Complete Response Letter
05/04/2023
 
 
TXT Members of Congress Seek Mifepristone Reversal
05/03/2023
 
 
TXT Rentschler Biopharma Germany Site 483
05/03/2023
 
 
TXT Lilly Eyes Fast OK for Donanemab in Alzheimer’s
05/03/2023
 
 
TXT GSK Wins Approval for 1st RSV Vaccine
05/03/2023
 
 
TXT ICH Quality Risk Management Guidance Published
05/03/2023
 
 
TXT Innovative Manufacturing Approaches Notice Corrected
05/03/2023
 
 
TXT PDUFA User Fee Assessment Guidance
05/03/2023
 
 
TXT Reps. Question FDA Pace for New Covid Therapeutics
05/03/2023
 
 
TXT Trade Groups Comment on Externally Controlled Trials
05/03/2023
 
 
TXT Smart Heart Toilet Seat Cleared by FDA
05/03/2023
 
 
TXT Accelerated Approval Withdrawals Likely to Increase: Attorneys
05/02/2023
 
 
TXT CGMP Violations in Voyant Beauty Inspection
05/02/2023
 
 
TXT Decentralized Clinical Trial Recommendations
05/02/2023
 
 
TXT DirectSync Gets ‘Breakthrough’ on Spinal Fusion Device
05/02/2023
 
 
TXT Vanda Says FDA Disclosed Trade Secrets to Competitors
05/02/2023
 
 
TXT FDA Finishes Posting OTC Drug Deemed Final Orders
05/02/2023
 
 
TXT FDA Partial Hold on Sun JAK Inhibitor Trial
05/02/2023
 
 
TXT Astellas/Pfizer Mulling sNDA for Xtandi
05/01/2023
 
 
TXT Bipartisan Bill on Preventing Drug Shortages
05/01/2023
 
 
TXT Complete Response on Hypoparathyroidism NDA
05/01/2023
 
 
TXT Princeton BioMeditech OTC Covid Test Authorized
05/01/2023
 
 
TXT Lilly Issued 483 on Aseptic Operations
05/01/2023
 
 
TXT Medtronic Next-Gen Micra Pacemakers Approved
05/01/2023
 
 
TXT Guide on Smoking Cessation Products
04/28/2023
 
 
TXT Comments on Data/Tech Strategic Plan
04/28/2023
 
 
TXT DTC Research to Examine Treatment Tradeoffs
04/28/2023
 
 
TXT Petition Seeks Removal of Bamboo’s NarxCare Software
04/28/2023
 
 
TXT Gene Therapy Guide on NonClinical Biodistribution
04/28/2023
 
 
TXT Teva Recalls Fentanyl Lots Over Product Insert
04/28/2023
 
 
TXT FDA Approves Otsuka/Lundbeck Schizophrenia Drug
04/28/2023
 
 
TXT ViiV Dovato Ad Claims Challenged
04/27/2023
 
 
TXT Drug Supply Chain Independence Bill
04/27/2023
 
 
TXT Ultromics Gets Breakthrough Status for AI Device
04/27/2023
 
 
TXT FDA Approves Oral Fecal Microbiota Capsules
04/27/2023
 
 
TXT Prevent Makena Compounding: Public Citizen
04/27/2023
 
 
TXT Gillibrand Bill to Speed FDA Approval of Some Drugs
04/27/2023
 
 
TXT Quality Management Maturity Dividing Industry: PDA
04/27/2023
 
 
TXT FDA Planning TV Ad Endorser Research
04/27/2023
 
 
TXT Lilly Planning Tirzepatide Submission Soon
04/27/2023
 
 
TXT FDA Lifts Warning Letter Against Medtronic
04/26/2023
 
 
TXT CVM Electronic Submission Registration
04/26/2023
 
 
TXT DefenCath NDA to be Resubmitted by Mid-May
04/26/2023
 
 
TXT Nonrandom Data Can Emulate Random Trials: Study
04/26/2023
 
 
TXT Iptacopan FDA Submission Coming Soon: Novartis
04/26/2023
 
 
TXT Alvotech FDA-483 Released
04/26/2023
 
 
TXT Bankrupt Akorn Recalls All Products
04/26/2023
 
 
TXT Vertex Gains Expanded Use for Cystic Fibrosis Drug
04/26/2023
 
 
TXT Advisors Asked About Olaparib sNDA Population
04/26/2023
 
 
TXT CGMP Violations at Egypt’s Pharmaplast
04/25/2023
 
 
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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;
  • 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