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 Laurus Synthesis FDA-483
01/03/2024
 
 
TXT Torrent Pharmaceuticals FDA-483
01/03/2024
 
 
TXT No FDA Funding for RADAR: Public Citizen
01/03/2024
 
 
TXT EUA Filed for Covid Prevention in Immunocompromised
01/03/2024
 
 
TXT FDA OKs Arcutis’ Zoryve Topical Foam for Dermatitis
01/02/2024
 
 
TXT Complete Response Letter for Zealand Infant Drug
01/02/2024
 
 
TXT FDA Updates Kite Yescarta Label
01/02/2024
 
 
TXT No Info from Singapore Drug Company
01/02/2024
 
 
TXT FDA Approves Ionis/AstraZeneca’s Wainua
01/02/2024
 
 
TXT Quality System Issues at Argentina’s Terragene
01/02/2024
 
 
TXT Turkish Drug Company Has CGMP Issues: FDA
01/02/2024
 
 
TXT Clinical Investigation Didn’t Follow Plan: FDA
01/02/2024
 
 
TXT Update on FDA Real-World Evidence Activities
01/02/2024
 
 
TXT Real-World Data Registries Guidance
01/02/2024
 
 
TXT ResMed Updates Labeling for Masks with Magnets
01/02/2024
 
 
TXT Rare Disease Drug Development Guidance
01/02/2024
 
 
TXT Drug Development Master Protocol Guidance
01/02/2024
 
 
TXT Updated Labeling for Promethazine HCl
01/02/2024
 
 
TXT Cell/Gene Product Potency Assurance
01/02/2024
 
 
TXT CGMP Violations at Patco Cosmetics
01/02/2024
 
 
TXT Don’t Use Counterfeit Ozempic: FDA
01/02/2024
 
 
TXT Califf Discusses More Clinical Research Options
01/02/2024
 
 
TXT Topical Ophthalmic Quality Guidance
01/02/2024
 
 
TXT CGMP Violations in Omeza Inspection
01/02/2024
 
 
TXT 2nd CRL for Merck’s Gefapixant Chronic Cough Drug
01/02/2024
 
 
TXT Medline Recalls Trach Care and Cleaning Trays
01/02/2024
 
 
TXT Insight Recalls 1 Lot of Americaine Topical Spray
01/02/2024
 
 
TXT Hua Da Trading Selling Unapproved Viagra: FDA
01/02/2024
 
 
TXT Hospira Recalls 1 Bleomycin Lot
01/02/2024
 
 
TXT QS Issues at Fresenius Medical Care
01/02/2024
 
 
TXT East Fork Cultivars Illegal CBD Products
01/02/2024
 
 
TXT Broadcast Ad ‘Major Statement’ Q&A Guide
01/02/2024
 
 
TXT Dextrum Laboratories CGMP Violations
01/02/2024
 
 
TXT FDA OKs Updated Carvykti Boxed Warning
01/02/2024
 
 
TXT Reformulating Drugs Containing Carbomers
01/02/2024
 
 
TXT Hospira Sodium Bicarbonate Recall
01/02/2024
 
 
TXT Botanical Be Selling Unapproved Drugs: FDA
01/02/2024
 
 
TXT FDA Approves AvertD Opioid Use Test
01/02/2024
 
 
TXT 10 Observations in Aurobindo Facility Inspection
01/02/2024
 
 
TXT Covid-19 Monoclonal Antibody EUA Guidance
01/02/2024
 
 
TXT Amazon Distributing Illegal Drugs: FDA
01/02/2024
 
 
TXT 510(k) Third Party Review EUA Guidance
01/02/2024
 
 
TXT FDA Issuing Device Electronic Export Documents
01/02/2024
 
 
TXT CGMP Violations in Inopak Inspection
01/02/2024
 
 
TXT ‘Deep Flaws’ in FDA Device Oversight: KFF Health News
01/02/2024
 
 
TXT Colonial Dames CGMP Violations
01/02/2024
 
 
TXT QS Violations at Sweden’s Sonesta Medical
01/02/2024
 
 
TXT DHT Remote Data Acquisition Guidance
01/02/2024
 
 
TXT CRL for Amgen Lumakras sNDA
01/02/2024
 
 
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
 
 
<< 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