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FDA-RELATED NEWS
 
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TXT PhRMA Supports Post-Approval Safety Guidance
05/22/2024
 
 
TXT Hypoglycemia Risk in Novo’s Weekly Insulin: FDA
05/22/2024
 
 
TXT Clin-Pharm Considerations for Oligonucleotides Guide
06/14/2024
 
 
TXT Teleflex/Arrow Recall Aortic Catheters
06/14/2024
 
 
TXT Getinge Recalls Vaporizer Sevoflurane Maquet Filling
06/14/2024
 
 
TXT Novavax Amends Covid Vaccine EUA
06/14/2024
 
 
TXT Guide on Diabetic Foot Infection Drugs
06/14/2024
 
 
TXT Amgen’s Blincyto Gets Expanded Leukemia Use
06/14/2024
 
 
TXT Pfizer Duchene Gene Therapy Fails Phase 3 Study
06/13/2024
 
 
TXT Emerging Drug Safety Technology Meeting Program
06/13/2024
 
 
TXT DSCSA Pilot Project Report Out
06/13/2024
 
 
TXT ICH M10 Bioanalytical Method Analysis Q&A Guidance
06/13/2024
 
 
TXT FDA Accelerated Approval for BMS’ Augtyro Cancer Drug
06/13/2024
 
 
TXT Megadyne Recalls Pediatric Return Electrodes
06/13/2024
 
 
TXT 3 Bayesian Examples Added to Demonstration Project
06/13/2024
 
 
TXT Supreme Court Rejects Mifepristone Lawsuit
06/13/2024
 
 
TXT FDA Revises Covid Vaccine Composition Recommendation
06/13/2024
 
 
TXT Submit Long Covid Drug as IND: FDA
06/12/2024
 
 
TXT 5 Teva ProAir Patents Ordered Out of Orange Book
06/12/2024
 
 
TXT FDA Platform Technology Designation Analyzed
06/12/2024
 
 
TXT Positive Results for Setrusumab in Bone Disease
06/12/2024
 
 
TXT FDA OKs Lilly’s Retevmo for Some Thyroid Cancers
06/12/2024
 
 
TXT Appropriators Slash FDA Budget by $450 Million
06/12/2024
 
 
TXT Getinge Clinical Decision Support Software Cleared
06/12/2024
 
 
TXT CGMP Violations at Malaysia’s TCT Neutraceuticals
06/11/2024
 
 
TXT Cosmetic Solutions CGMP, Unapproved Drug Violations
06/11/2024
 
 
TXT Drug QA Inspections Up 40%: Report
06/11/2024
 
 
TXT Upcoming CDRH eMDR Enhancements
06/11/2024
 
 
TXT Medline Recalls Sub-G Endotracheal Tube
06/11/2024
 
 
TXT Concerns With Alzheimer’s Drug Development Guidance
06/11/2024
 
 
TXT Women Underrepresented in Device Trials: Research
06/11/2024
 
 
TXT Ipsen Gains Accelerated OK for Iqirvo
06/11/2024
 
 
TXT Arthritis Advisory Panel Renewed for 2 Years
06/10/2024
 
 
TXT Emerging Drug Safety Technology Meeting Program
06/10/2024
 
 
TXT GSK’s Arexvy Gets Expanded Approval
06/10/2024
 
 
TXT FDA Clears 2 Abbott OTC Glucose Monitors
06/10/2024
 
 
TXT FDA Panel Backs Lilly’s Alzheimer’s Drug
06/10/2024
 
 
TXT Geron Myelodysplastic Syndromes NDA Approved
06/07/2024
 
 
TXT CDER Proposes to Deny Vanda Hetlioz sNDA
06/07/2024
 
 
TXT DePuy Synthes Gets 510(k) for Robotic Knee Device
06/07/2024
 
 
TXT Cipla Gets 1-item 483 After May Inspection
06/07/2024
 
 
TXT Moon Surgical’s Maestro Surgical Device Cleared
06/07/2024
 
 
TXT 236 Potential Drug Shortages Prevented in 2023: FDA
06/06/2024
 
 
TXT Replimune Plans RP1 BLA After Positive Trial Data
06/06/2024
 
 
TXT Agency Debars Sievert for 10 Years
06/06/2024
 
 
TXT FDA Reviewers Air Alzheimer’s Drug Issues
06/06/2024
 
 
TXT GAO Cites OTC Hearing Aid Issues
06/06/2024
 
 
TXT Reps Seek Info for ‘Next Generation Cures’
06/06/2024
 
 
TXT Workshop on AI Use in Drug/Biologic Development
06/06/2024
 
 
TXT Pediatric Orthopedic Device Innovation ‘Lags’: Research
06/06/2024
 
 
TXT FDA Places Hold on Biomea Diabetes Trials
06/06/2024
 
 
TXT BIMO Electronic Submission Format Guidance
06/05/2024
 
 
TXT Drug Shortages at Decade High, Last Longer: USP
06/05/2024
 
 
TXT Panel Backs JN.1 Variant-Targeted Covid Vaccine
06/05/2024
 
 
TXT Amgen: Positive Data on Uplizna in Ig G4 Disease
06/05/2024
 
 
TXT FDA Denies Nautilus Glove Reconsideration Request
06/05/2024
 
 
TXT Questions on Alzheimer’s Drug Draft Guidance
06/05/2024
 
 
TXT Medtronic Recalls Malfunctioning StealthStation Software
06/05/2024
 
 
TXT Trexo Robotics Illegally Marketing Devices: FDA
06/05/2024
 
 
TXT Info Collection on Device Recall Authority
06/04/2024
 
 
TXT FDA Promoting ‘Pragmatic Clinical Research’: Califf
06/04/2024
 
 
TXT BMS Reports Positive Opdivo plus Yervoy Data
06/04/2024
 
 
TXT Multiple QS Issues in Techlem Inspection
06/04/2024
 
 
TXT Arrow Recalls FiberOptix Intra-Aortic Catheter
06/04/2024
 
 
TXT 3 Comments on BA/BE Data Integrity Guidance
06/04/2024
 
 
TXT BIMO Processes and Practices Guidance
06/04/2024
 
 
TXT Jiangsu Hengrui Inspection Nets 8-item 483
06/04/2024
 
 
TXT Streamline and Update Biosimilar Development: Council
06/04/2024
 
 
TXT Takeda Moving Narcolepsy Drug to Phase 3
06/03/2024
 
 
TXT FDA Clears Kenota Health IgE Test
06/03/2024
 
 
TXT FDA Debars Punjani Over Imported Generic Viagra
06/03/2024
 
 
TXT Agios Filing NDA on Thalassemia Drug
06/03/2024
 
 
TXT FDA Extends Review of Dupixent in COPD
05/31/2024
 
 
TXT Final Rule Allows Imported Device Destruction
05/31/2024
 
 
TXT Gilead Misses on Trodelvy Confirmatory Study
05/31/2024
 
 
TXT FDA Raises Safety/Efficacy Issues with Lykos PTSD Drug
05/31/2024
 
 
TXT Moderna RSV Vaccine Approved by FDA
05/31/2024
 
 
TXT Scant Evidence for Accelerated Approval Markers: Study
05/30/2024
 
 
TXT Merck sBLA for Keytruda/Chemo in Mesothelioma
05/30/2024
 
 
TXT ‘Defense-Friendly’ 5th Circuit Decision for Hospira
05/30/2024
 
 
TXT FDA Denies Novartis’ Entresto Petition
05/30/2024
 
 
TXT OptumHealth Recalls Nimbus Infusion Pumps
05/30/2024
 
 
TXT Office of Regulatory Affairs, Other Changes Approved
05/30/2024
 
 
TXT Uses of and Issues with AI in Trial Design
05/30/2024
 
 
TXT CDER Lists 10 Pharmaceutical Quality Functions
05/29/2024
 
 
TXT Medline Recalls Endotracheal Tube
05/29/2024
 
 
TXT Disclose ‘Locked’ Hearing Aids: Members of Congress
05/29/2024
 
 
TXT ICH M12 Drug Interaction Guideline Out
05/29/2024
 
 
TXT FDA Oks Amgen’s Bkemv as Soliris Biosimilar
05/29/2024
 
 
TXT Lab Association Sues FDA Over LDT Rule
05/29/2024
 
 
TXT Info Collection on Device De Novo Requests
05/28/2024
 
 
TXT Ostar Beauty Selling Unapproved Medical Devices: FDA
05/28/2024
 
 
TXT Multiple Violations in Lengthy Biomic Inspection
05/28/2024
 
 
TXT Teva Spurns FDA’s Beta-Lactam Drug Recommendation
05/28/2024
 
 
TXT ICH Pharmacoepidemiological Study Guidance Out
05/28/2024
 
 
TXT Sanofi Sarclisa sBLA Accepted for Priority Review
05/28/2024
 
 
TXT Lawmakers Want FDA Jurisdiction on Execution Drugs
05/24/2024
 
 
TXT Respironics Recalls OmniLab Ventilator
05/24/2024
 
 
TXT Panel Backs Shield Colon Cancer Test
05/24/2024
 
 
TXT Hospira Recalls Buprenorphine and Laberalol Lots
05/24/2024
 
 
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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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