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FDA-RELATED NEWS
 
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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
 
 
TXT GLP Report Translation Q&A Guidance
11/21/2023
 
 
TXT Concerns Over FDA Biosimilar Labeling Draft Guide
11/21/2023
 
 
TXT Repeat CGMP Violations at Cipla Plant
11/21/2023
 
 
TXT Study New Guide on Science Info for MDs: Attorneys
11/21/2023
 
 
TXT Abecma Review Delayed for Panel Input
11/20/2023
 
 
TXT Info Sought on Supply Chain Security
11/20/2023
 
 
TXT Final Rule on DTC Ads’ Major Statements
11/20/2023
 
 
TXT Bayer Stops Stroke Drug Study Over Inferiority
11/20/2023
 
 
TXT FDA Warns on Monoject Syringes
11/20/2023
 
 
TXT Janssen Seeks Expanded Rybrevant Use
11/20/2023
 
 
TXT Medtronic’s Symplicity for Hypertension Approved
11/20/2023
 
 
TXT Dr. Reddy’s Issued 10-item FDA-483
11/17/2023
 
 
TXT FDA OKs AstraZeneca Breast Cancer Drug
11/17/2023
 
 
TXT Merck’s Keytruda Gains OK in Gastric Cancer
11/17/2023
 
 
TXT Asensus Surgical Recalls Robot Devices
11/17/2023
 
 
TXT Device Discontinuance and 506J List Guidances
11/16/2023
 
 
TXT FDA Publishes 40 Product-Specific Guidances
11/16/2023
 
 
TXT Device Computational Modeling Credibility Guide
11/16/2023
 
 
TXT U.S. Drug Shortages Increasing: Report
11/16/2023
 
 
TXT Provide Covid Therapeutics Distribution Info: Califf
11/16/2023
 
 
TXT Janet Woodcock Retiring in Early 2024
11/16/2023
 
 
TXT Managing Legacy Device Cyber Risks
11/16/2023
 
 
TXT Product Testing Alternative Methods
11/15/2023
 
 
TXT CGMP Violations in Turkish OTC Drug Manufacturer
11/15/2023
 
 
TXT FDA Punts Merck Cough Drug Data to Panel
11/15/2023
 
 
TXT Califf Backs Evidence Generation Report
11/15/2023
 
 
TXT Baxter Recalls Novum IQ Infusion Pump
11/15/2023
 
 
TXT Smart Women’s Choice Consent Decree
11/15/2023
 
 
TXT IceCure Medical Appeals De Novo Denial
11/15/2023
 
 
TXT QS Violations at Ming Fai Industrial
11/14/2023
 
 
TXT ‘Insanitary Conditions’ at India’s Global Pharma
11/14/2023
 
 
TXT Bayer Withdrawing Aliqopa After Failed Study
11/14/2023
 
 
TXT Former BD Exec Petitions FDA on Mesh Products
11/14/2023
 
 
TXT ODAC Looking at Long Delays in 2 Acrotech Trials
11/14/2023
 
 
TXT Comments on Cell & Gene Comparability Guide
11/14/2023
 
 
TXT Imfinzi Phase 3 Trial Fails
11/14/2023
 
 
TXT FDA Lawyer Nguyen Moves to Cooley
11/14/2023
 
 
TXT Congress Should Do More on Drug Shortages: Analysis
11/14/2023
 
 
TXT Improve Post-Market Evidence Generation: Report
11/14/2023
 
 
TXT Covidien Recalls Stolen Video Laryngoscopes
11/13/2023
 
 
TXT Republicans Threaten Subpoena on FDA Research
11/13/2023
 
 
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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;
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