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FDA-RELATED NEWS
 
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TXT CDER Working on Pediatric Extrapolation Framework
08/18/2022
 
 
TXT Medical Device Recalls Up in 2nd Quarter: Sedgwick
08/18/2022
 
 
TXT Radiolabeled Mass Balance Study Comments
08/17/2022
 
 
TXT Final Rule on OTC Hearing Aids
08/17/2022
 
 
TXT Preceptis Device Cleared for Ear Tube Procedures
08/17/2022
 
 
TXT Makena NDA Withdrawal Hearing 10/17-19
08/16/2022
 
 
TXT Drug Inspections at ‘Operational Levels’: Throckmorton
08/16/2022
 
 
TXT Emergent BioSolutions Warning Letter Out
08/16/2022
 
 
TXT Case Safety Report Transmission Guide
08/16/2022
 
 
TXT Pharma CEO Pleads Guilty to FDA False Statements
08/15/2022
 
 
TXT FDA Extends Review of Reata Pharma NDA
08/09/2022
 
 
TXT Appeals Court Overturns Preemption-related Dismissal
08/08/2022
 
 
TXT Myfembree Wins OK for Endometriosis Pain
08/08/2022
 
 
TXT CDRH Wants Proposals on Device Learning Site Visits
08/05/2022
 
 
TXT Humira ‘Patent Thicket’ Case Dismissal Affirmed
08/04/2022
 
 
TXT Charles River Wants Endotoxin Assay Regulation
08/03/2022
 
 
TXT FDA Working to Cut Ethylene Oxide Emissions
08/03/2022
 
 
TXT Juvéderm Volux XC Approved for Jawline Shaping
08/03/2022
 
 
TXT FDA Approves Cimerli as Generic Lucentis
08/03/2022
 
 
TXT Looking at the FDA/Industry ‘Revolving Door’
08/03/2022
 
 
TXT Alnylam Pharmaceuticals Plans NDA for Patisiran
08/03/2022
 
 
TXT False Claims Liability for Medical Device Off-Label Use
08/03/2022
 
 
TXT Allarity Refocuses in Response to FDA Comments
08/02/2022
 
 
TXT Guide on N-Acetyl-L-Cysteine Enforcement Discretion
08/02/2022
 
 
TXT CDRH Still Working on AL/MI Guidance: Attorneys
08/02/2022
 
 
TXT Priority Review for Gamida’s Omidubicel
08/02/2022
 
 
TXT ImmunityBio Files BLA for Bladder Cancer Therapy
08/01/2022
 
 
TXT Hold Lifted on Celyad Oncology CAR T Therapy
08/01/2022
 
 
TXT AstraZeneca Scraps Monalizumab Clinical Study
08/01/2022
 
 
TXT FTC Endorsement Guides Require Attention: Lawyer
07/29/2022
 
 
TXT Opioid Questions Continue to Dog Califf: AP
07/28/2022
 
 
TXT Share All Cancer Drug Approval Data: Study
07/28/2022
 
 
TXT 3 Lessons Learned from Fosamax ‘Failure-to-Warn’ Case
07/28/2022
 
 
TXT Micro-Organospheres Show Cancer Proof of Concept: NCI
07/28/2022
 
 
TXT Covidien Recalls Palindrome and Mahurkar Catheters
07/28/2022
 
 
TXT Cassava Sciences Under Criminal Investigation: Reuters
07/27/2022
 
 
TXT FDA OKs Bavarian Nordic’s Vaccine Facility
07/27/2022
 
 
TXT Non-Curative Setting Available Therapy
07/27/2022
 
 
TXT Viz.ai Subdural Hemorrhage Detector Cleared
07/27/2022
 
 
TXT Lexicon Re-files NDA for Heart Failure Drug
07/27/2022
 
 
TXT Cannabis Administration and Opportunity Act
07/27/2022
 
 
TXT ‘Objectionable Conditions’ in Goodman Eye Center Trial
07/27/2022
 
 
TXT CGMP Violations in Bi-Coastal Pharma Inspection
07/26/2022
 
 
TXT API Deviations Found at Jost Chemical
07/26/2022
 
 
TXT Avadel Sues FDA Over Lumryz NDA Delay
07/26/2022
 
 
TXT Develop Regulatory Framework for Synthetic Cells: Paper
07/26/2022
 
 
TXT FDA Accepts Biogen Tofersen NDA for Rare ALS
07/26/2022
 
 
TXT FDA Grants Taiho Oncology Lonsurf Petition
07/26/2022
 
 
TXT Many Supplements Stay on Market After FDA Warning
07/26/2022
 
 
TXT Biotronik Pays $13 Million Under False Claims Case
07/25/2022
 
 
TXT Zipperer Debarred by FDA for 5 Years
07/25/2022
 
 
TXT Draft Guide on Real-time Oncology Reviews
07/25/2022
 
 
TXT Compliance Extension Date on Unique Device IDs
07/22/2022
 
 
TXT FDA Proposes to Move to 12-digit National Drug Codes
07/22/2022
 
 
TXT Regulatory Review Didn’t Slow Covid Vaccines: Marks
07/21/2022
 
 
TXT BioCircuit Technologies 510(k) for Nerve Tape
07/21/2022
 
 
TXT Orange Book Therapeutic Equivalence Guide
07/21/2022
 
 
TXT New Renuvion/J-Plasma Handpiece Available: FDA
07/21/2022
 
 
TXT Whitmer Wants Mifepristone REMS Lifted
07/21/2022
 
 
TXT CGMP Problems at Catalent Pharma Solutions
04/08/2008
 
 
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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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