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FDA-RELATED NEWS
 
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TXT Ozempic Mental Health Issues Up: NPR
09/21/2023
 
 
TXT Merck sBLA for Keytruda Use in Cervical Cancer
09/21/2023
 
 
TXT Orphan Drug Designation for Puma’s Alisertib
09/21/2023
 
 
TXT FDA Dismisses Novo Nordisk Inspection Concerns
09/21/2023
 
 
TXT ‘Major Disruption’ Clinical Trial Guidance
09/20/2023
 
 
TXT Industry Fights FDA on Drug Shortage Fixes: Califf
09/20/2023
 
 
TXT FDA Reviewers Again Nix Intarcia Diabetes Product
09/20/2023
 
 
TXT Drug Preemption Defense Demanding, Attainable: Attorneys
09/20/2023
 
 
TXT Taysha Discontinues Gene Therapy Program
09/20/2023
 
 
TXT UCB Faces Another Review Delay on Bimekizumab
09/20/2023
 
 
TXT FDA Recalls Saline Solution
09/20/2023
 
 
TXT CRL for ARS Pharmaceuticals’ Neffy
09/20/2023
 
 
TXT Kimera Labs Illegally Marketing Exosomes: FDA
09/19/2023
 
 
TXT CDRH International Harmonization Plan
09/19/2023
 
 
TXT More 510(k) Changes Likely: Attorneys
09/19/2023
 
 
TXT FDA Converts ASCA from Pilot to Permanent
09/19/2023
 
 
TXT Houston Man Sentenced in Counterfeit Drugs Case
09/19/2023
 
 
TXT Vanda Hetlioz Dispute with FDA Heats Up
09/19/2023
 
 
TXT CGMP, Other Violations at PureChemPros
09/19/2023
 
 
TXT Breakthrough for Parkinson’s Neurostimulator
09/19/2023
 
 
TXT English Doctor Attacks FDA/CDC Covid Vaccine Data
09/18/2023
 
 
TXT Drug Use-related Software Labeling Guide
09/18/2023
 
 
TXT Substantial Evidence from 1 Trial Guidance
09/18/2023
 
 
TXT Petition Denied on Tacrolimus Bioequivalence
09/18/2023
 
 
TXT Vision Patient-reported Outcomes Workshop
09/18/2023
 
 
TXT Novo Nordisk Gets FDA-483: Reports
09/18/2023
 
 
TXT FDA Extends BLA Review of Melanoma Therapy
09/15/2023
 
 
TXT Digital Health Frequently Asked Questions
09/15/2023
 
 
TXT Beacon Biosignals 510(k) for Sleep Monitor
09/15/2023
 
 
TXT FDA OKs GSK’s Blood Cancer Drug
09/15/2023
 
 
TXT Draft Guide on Biosimilar/Interchangeable Labeling
09/15/2023
 
 
TXT Voluntary Improvement Program Guidance
09/14/2023
 
 
TXT Breakthrough Devices Updated Final Guidance
09/14/2023
 
 
TXT Forms FDA 3988 and 3989 Guidance
09/14/2023
 
 
TXT AI is FDA Info Technology Plan’s Top Goal
09/14/2023
 
 
TXT FDA 2 Weight Loss Device Guidances
09/14/2023
 
 
TXT FTC Warns on Improper Orange Book Patent Listings
09/14/2023
 
 
TXT FDA Clarifies Safety of Phenylephrine Products
09/14/2023
 
 
TXT FDA, Rocket Agree on Phase 2 Danon Disease Trial
09/13/2023
 
 
TXT Safety Concerns Stop Eiger Phase 3 Hepatitis Trial
09/13/2023
 
 
TXT Supremes May Hear Label Preemption Case: Attorneys
09/13/2023
 
 
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
 
 
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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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  • Related industry news capsules;
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