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FDA-RELATED NEWS
 
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TXT Include ICH Q12 in Gene Therapy Guidance: ISPE
09/13/2023
 
 
TXT White House Credits FDA on Drug Shortages
09/13/2023
 
 
TXT Abbott Recalls Proclaim Pulse Generators
09/13/2023
 
 
TXT ‘Good Cause’ Guidance Needs Flexibility: PhRMA
09/13/2023
 
 
TXT Bipartisan Legislation on Patent Listings
09/13/2023
 
 
TXT FDA Questions Efficacy of Patisiran sNDA
09/12/2023
 
 
TXT FY 2022 GDUFA Science, Research Outcomes
09/12/2023
 
 
TXT Safecor Health CGMP Violations
09/12/2023
 
 
TXT Similasan Marketing Unapproved New Drugs: FDA
09/12/2023
 
 
TXT FDA Warns 8 Firms for Unapproved Eye Drugs
09/12/2023
 
 
TXT CDER Defends Pepaxto Withdrawal Proposal
09/12/2023
 
 
TXT 2 FDA Recommendations in Patient Safety Report
09/12/2023
 
 
TXT White Paper on Preventing Drug Shortages
09/12/2023
 
 
TXT Panel Votes Down OTC Cold Ingredient
09/12/2023
 
 
TXT Mallinckrodt Recalls One-Way Ventilator Valve
09/12/2023
 
 
TXT Jury Convicts 2 for Clinical Trial Fraud
09/12/2023
 
 
TXT FDA Permanently Debarring Tatsene
09/12/2023
 
 
TXT 45 Device Alerts Issued in 2022: FDA
09/11/2023
 
 
TXT Justice Petitions Supreme Court Over Mifeprex
09/11/2023
 
 
TXT Updated Covid-19 Vaccines Approved by FDA
09/11/2023
 
 
TXT Tagrisso Phase 3 Data in Lung Cancer
09/11/2023
 
 
TXT Guide on Peptide Clin-Pharm Considerations
09/11/2023
 
 
TXT CMC Readiness Pilot Program
09/11/2023
 
 
TXT Novartis Recalls Sandimmune Lot
09/11/2023
 
 
TXT FDA Updates Alert on Halyard N95 Masks
09/08/2023
 
 
TXT Senators Reintroduce Opioid Studies Bill
09/08/2023
 
 
TXT House Committee Hearing on Drug Shortages
09/08/2023
 
 
TXT Subcutaneous Tecentrig Delayed Due to CMC Info
09/08/2023
 
 
TXT GAO Report Probes Device DTC Advertising
09/08/2023
 
 
TXT Danco Seeks High Court Abortion Drug Review
09/08/2023
 
 
TXT ISO 10993-1 Clarifying Guidance
09/07/2023
 
 
TXT No Marketing of Same Rx and OTC Drugs: Reps
09/07/2023
 
 
TXT Philips $615 Million Settlement Over Faulty Devices
09/07/2023
 
 
TXT Janssen Stops Macitentan Phase 3 Study
09/07/2023
 
 
TXT FDA Update on Bone Matrix TB Issue
09/07/2023
 
 
TXT Human Factors Engineering Q&A Guidance
09/07/2023
 
 
TXT Suggestions for ICH Good Clinical Practice Guideline
09/07/2023
 
 
TXT 3 New 510(k) Guidances
09/06/2023
 
 
TXT Positron Emission Tomography Meeting Set
09/06/2023
 
 
TXT Rybrevant Hits Phase 3 Goals in Some Lung Cancers
09/06/2023
 
 
TXT FDA Denies ICAN Pertussis Labeling Petition
09/06/2023
 
 
TXT ‘Strong Response’ in New Moderna Covid Vaccine
09/06/2023
 
 
TXT FDA, Flatiron Health Real-world Data Pact
09/06/2023
 
 
TXT Breakthrough Status on Auto Glucose Device
09/06/2023
 
 
TXT Appeals Court Reverses Ivermectin Suit Dismissal
09/05/2023
 
 
TXT Techsomed Ablation Planning Software Cleared
09/05/2023
 
 
TXT CGMP Violations at Lex, Inc.
09/05/2023
 
 
TXT Mycobacterial Pulmonary Disease Draft Guide
09/05/2023
 
 
TXT Generic Drug Warning Letter Meetings Guide
09/05/2023
 
 
TXT Meeting on Reauthorizing OTC Drug User Fees
09/05/2023
 
 
TXT Green Pharma Warned Over CGMP Issues
09/05/2023
 
 
TXT Interoperable Info Exchange Guidance
09/05/2023
 
 
TXT Robot Authorized to Disinfect Medical Surfaces
09/05/2023
 
 
TXT ‘Urgent Action’ on Puberty Blockers Sought
09/05/2023
 
 
TXT FDA Informed Consent Final Guidance
09/05/2023
 
 
TXT Primary Endpoint Met in Alecensa Study: Roche
09/01/2023
 
 
TXT Guide on Mycobacterial Pulmonary Disease
09/01/2023
 
 
TXT Generic Post-Warning Letter Meetings Guide
09/01/2023
 
 
TXT More Variants Cleared for 23andMe Genetic Test
09/01/2023
 
 
TXT Universal Meditech Recalls All Test Products
09/01/2023
 
 
TXT Hugel Refiles BLA Addressing FDA Concerns
09/01/2023
 
 
TXT Sage Reorganizing to Support Zurzuave Launch
08/31/2023
 
 
TXT BD Suggestions for Microbiology Panel
08/31/2023
 
 
TXT Guide on Real-World Data/Evidence
08/31/2023
 
 
TXT AdvaMed on At-Home Medical Technology Use
08/31/2023
 
 
TXT Fight Bone Graft Infections: Michigan Lawmakers
08/31/2023
 
 
TXT Keep FDA Logo Out of Materials: Agency
08/31/2023
 
 
TXT FDA Quality Management White Paper
08/31/2023
 
 
TXT Opioid Crisis Worse Despite Progress: Califf
08/31/2023
 
 
TXT Real-World Evidence Regulatory Guidance
08/30/2023
 
 
TXT FibroGen Duchenne Study Misses Endpoint
08/30/2023
 
 
TXT Hamilton Medical Recalls Ventilators
08/30/2023
 
 
TXT Drug Distribution Security Guidance
08/30/2023
 
 
TXT Drug Tracing ‘Stabilization Period’
08/30/2023
 
 
TXT Comments on Increasing Home Medical Tech Use
08/30/2023
 
 
TXT FDA Renews 5-Year M-CERSI Agreement
08/30/2023
 
 
TXT Breakthrough Designation for Quest Diagnostic
08/30/2023
 
 
TXT RAISE Program Explained
08/30/2023
 
 
TXT CGMP Violations at K.C. Pharmaceuticals
08/29/2023
 
 
TXT Gadal Laboratories CGMP Violations
08/29/2023
 
 
TXT Tesla BioHealing Illegally Marketing Devices
08/29/2023
 
 
TXT FDA Monitoring Social Media Drug Promotion: Post
08/29/2023
 
 
TXT 9 GA Congress Members Want Chemo Transparency
08/29/2023
 
 
TXT FDA Promotes Dose Optimization Innovation: Report
08/29/2023
 
 
TXT Texas Approves Drug Import Plan
08/29/2023
 
 
TXT Lawmakers Ask FDA to Fix Orange Book Loopholes
08/29/2023
 
 
TXT ICU Medical Infusion Pump Cleared
08/29/2023
 
 
TXT Janssen Files sBLA for Expanded Rybrevant
08/28/2023
 
 
TXT Data Integrity Issues at Synapse Labs: Petition
08/28/2023
 
 
TXT FDA Clears BioProtect Balloon Implant
08/28/2023
 
 
TXT AbbVie sBLA for Skyrizi in Crohn’s
08/28/2023
 
 
TXT Novocure Phase 3 Study Misses Primary Endpoint
08/28/2023
 
 
TXT Merck, Eisai Stop LEAP-010 Trial
08/25/2023
 
 
TXT Enforcement Deferred on Drug Security Needs
08/25/2023
 
 
TXT Comments Sought on Pepaxto’s Proposed Withdrawal
08/25/2023
 
 
TXT CDRH Qualifies Tool on Material Biostability
08/25/2023
 
 
TXT FDA OKs New Veklury Covid Indication
08/24/2023
 
 
TXT Akebia Plans 3rd Quarter Vadadustat NDA Resubmission
08/24/2023
 
 
TXT Fast Track for Abdominal Aneurysm Product
08/24/2023
 
 
TXT Paragonix Donor Lung Preservation Device Cleared
08/24/2023
 
 
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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