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FDA-RELATED NEWS
 
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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
 
 
TXT Alpha Cognition NDA for Alzheimer’s Filed
12/07/2023
 
 
TXT Positive Phase 1/2 Linvoseltamab Results to FDA
12/07/2023
 
 
TXT Pediatric Drug Development Bill Introduced
12/07/2023
 
 
TXT Action Against BPI Methylene Blue Injection Asked
12/07/2023
 
 
TXT Restrict ANDAs for Generic Xipere: Bausch & Lomb
12/07/2023
 
 
TXT Merck Halts Keytruda Lung Cancer Trial
12/07/2023
 
 
TXT Pro Publica Slams FDA on Respirator Recall
12/07/2023
 
 
TXT FDA Sets Bulk Substance Compounding Policy
12/06/2023
 
 
TXT FDA Grants, Denies Provepharm ProvayBlue Petition
12/06/2023
 
 
TXT Novartis’ Fabhalta for PNH Approved
12/06/2023
 
 
TXT Probe FDA ‘Cozy Relationship’ with Pharma: Rep. Harris
12/06/2023
 
 
TXT Restrict ANDAs for Generic Zoryve: Arcutis
12/06/2023
 
 
TXT eSTAR e-Submissions Open for PMAs
12/06/2023
 
 
TXT CBER Helping to Speed Gene Therapies: Marks
12/06/2023
 
 
TXT Opdivo sBLA for Bladder Cancer
12/06/2023
 
 
TXT Animal Drug Regulations Amended
12/06/2023
 
 
TXT Industry Concerns with Predicate Device Guide
12/06/2023
 
 
TXT Review Extended on Sinus Drug
12/06/2023
 
 
TXT Oncology Center Pact on Real-world Evidence
12/05/2023
 
 
TXT Belmont Eyecare Selling Unapproved Eye Drops: FDA
12/05/2023
 
 
TXT MONARCH 3 Results Show Verzenio Success: Lilly
12/05/2023
 
 
TXT How FDA ‘One-stop’ PJOs Help Combo Industry
12/05/2023
 
 
TXT No Safety Issues in Biosimilar Switches: CDER Research
12/05/2023
 
 
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
 
 
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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;
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