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FDA-RELATED NEWS
 
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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
 
 
TXT Florida Files 2nd Drug Import Suit Against FDA
04/25/2023
 
 
TXT QS, MDR, Other Violations in Medivance Inspection
04/25/2023
 
 
TXT Medolife Illegally Selling Unapproved New Drugs: FDA
04/25/2023
 
 
TXT Streamlined Cancer Trials Can Cause ‘Discomfort’: Singh
04/25/2023
 
 
TXT Biogen Accelerated Approval for ALS Drug
04/25/2023
 
 
TXT Senate Bipartisan Agreement on FDA Reform Bills
04/25/2023
 
 
TXT FDA Sends ‘Non-Compliance’ Letter to Sun Pharma
04/25/2023
 
 
TXT Medtronic’s MiniMed 780G Gets FDA Approval
04/24/2023
 
 
TXT Generic Group Questions Guide on Guidance Meetings
04/24/2023
 
 
TXT Foghorn Therapeutics Hit with Partial Clinical Hold
04/24/2023
 
 
TXT Supreme Court Gives FDA Temporary Victory
04/24/2023
 
 
TXT OPDP Plans Survey on DTC Quantitative Claims
04/24/2023
 
 
TXT Avanos Medical Recalls Respiratory Suction Device
04/21/2023
 
 
TXT FDA Extends Review of Daiichi Leukemia NDA
04/21/2023
 
 
TXT CDER Denies Bausch Petition on Duobrii ANDAs
04/21/2023
 
 
TXT Novartis Gets Another Facility OK’d for Pluvicto
04/21/2023
 
 
TXT DTC Research Raises Concern on Endpoints in Cancer Ads
04/21/2023
 
 
TXT 10 Observations in Lupin FDA-483
04/20/2023
 
 
TXT Sarepta Comments on Golodirsen PSG
04/20/2023
 
 
TXT GE Healthcare’s Carescape Patient Monitor Cleared
04/20/2023
 
 
TXT FDA Describes New QSAR Model
04/20/2023
 
 
TXT FDA Failed to Collect $45 bil. Drug Trial Fines: Students
04/20/2023
 
 
TXT Califf Testifies on Accelerated Approvals
04/20/2023
 
 
TXT BelGene Gastric Cancer Drug Trial Hits Primary Endpoint
04/20/2023
 
 
TXT CGMP Violations at Zermat International
04/19/2023
 
 
TXT Fresenius Kabi Recalls Ivenix Infusion Device
04/19/2023
 
 
TXT North American Diagnostics Illegal Covid Tests
04/19/2023
 
 
TXT Radiation Syndrome Drug Development Guidance
04/19/2023
 
 
TXT NCI Sees Revumenib Promise for Some Leukemias
04/19/2023
 
 
TXT FDA Cautions Compounders on Bulk Sources
04/19/2023
 
 
TXT FDA Drug Inspections Slow to Recover: Analysis
04/19/2023
 
 
TXT Guidance Shows Importance of Sponsor Oversight: Attorneys
04/19/2023
 
 
TXT Generic Mifepristone Maker Sues FDA
04/19/2023
 
 
TXT High Court Adds 2 Days to Mifepristone Stay
04/19/2023
 
 
TXT EMA/FDA Bioequivalence Info Sharing Pact Adds Ireland
04/19/2023
 
 
TXT FDA OKs 2nd Covid Booster for Some People
04/18/2023
 
 
TXT Lessons Learned from Rare Disease Trials During Covid
04/18/2023
 
 
TXT OND Expands Regulatory Science Research
04/18/2023
 
 
TXT Intarcia Raises NDA Advisory Committee Issues
04/18/2023
 
 
TXT House Oversight Panel Puts Heat on FDA Over CBD
04/18/2023
 
 
TXT Research Describes Drug Ad Data Display
04/18/2023
 
 
TXT Royal Chemical Inspection Finds CGMP Violations
04/18/2023
 
 
TXT Multiple Abbott i-STAT Test Violations
04/18/2023
 
 
TXT Workshop on Rare Disease Endoints
04/17/2023
 
 
TXT Panel Backs Rexulti for Alzheimer’s Agitation
04/17/2023
 
 
TXT FDA Clears Reader for FreeStyle Libre 3
04/17/2023
 
 
TXT Avenue Therapeutics Plans IV Tramadol Resubmission
04/17/2023
 
 
TXT GSK Plans NDA for Antibiotic Gepotidacin
04/17/2023
 
 
TXT FDA ‘Top Cop’ McMeekin Retiring 6/30, Then Many More
04/17/2023
 
 
TXT Gamida Cell Therapy Approved by FDA
04/17/2023
 
 
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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:
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