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FDA-RELATED NEWS
 
 
 
TXT FDA Working on Januvia Shortage
08/10/2022
 
 
TXT FDA Clears Bodyport Cardiac Fluid Scale
08/09/2022
 
 
TXT CorMedix Hit With 2nd Complete Response on DefenCath
08/09/2022
 
 
TXT Objectionable Conditions at Valley Biosystems
08/09/2022
 
 
TXT Understanding Drug Risks and Benefits in Tweets
08/09/2022
 
 
TXT 50 NDAs Not Withdrawn Due to Safety/Efficacy: FDA
08/09/2022
 
 
TXT Appeals Court Affirms Dismissal of FOIA Case
08/09/2022
 
 
TXT FDA Says Haimen Shengbang Container Recall Class 1
08/09/2022
 
 
TXT European Data Privacy Law Affects FDA: Attorney
08/09/2022
 
 
TXT Reata Faces FDA Efficacy Scrutiny on Omaveloxolone
08/08/2022
 
 
TXT Acadia Gets 2nd Complete Response on Alzheimer's Drug
08/05/2022
 
 
TXT Woodcock Outlines IT Transformation at FDA
08/04/2022
 
 
TXT Resume User Fee Talks: Disease Interests
08/04/2022
 
 
TXT Regenxbio to File BLA for Hunter Syndrome Treatment
08/04/2022
 
 
TXT Aurobindo Hit with FDA-483 After Inspection
08/04/2022
 
 
TXT Data Don't Support Breakthrough for 510(k)s: Attorney
08/03/2022
 
 
TXT CGMP and Other Violations at DSP Skin Care
08/02/2022
 
 
TXT IND-Exempt BA/BE Study Guidance
08/02/2022
 
 
TXT FDA Corrects Notice on ANDA Withdrawals
07/29/2022
 
 
TXT Califf Warns on User Fee Layoff Notices in September
07/29/2022
 
 
TXT Guide on Disposable Drug Manufacturing Materials
07/29/2022
 
 
TXT Omeros Gets Orphan Status for PNH Therapy
07/29/2022
 
 
TXT Regulatory Review Period for Acceleron’s Reblozyl
07/29/2022
 
 
TXT Siemens Healthineers Angiography System Cleared
07/29/2022
 
 
TXT Some UV Wands are Unsafe: FDA
07/28/2022
 
 
TXT 1st Year Generic Drug Cluster Accomplishments
07/28/2022
 
 
TXT Neonatal Study Pharmacology Considerations
07/27/2022
 
 
TXT Expanding Use of Remote Regulatory Assessments: Guide
07/22/2022
 
 
TXT 6 Ways to Improve Trial Diversity
07/21/2022
 
 
TXT Pfizer’s Xalkori OK’d for Myofibroblastic Tumors
07/15/2022
 
 
TXT Califf on Tweaking Accelerated Approvals, No Big Revamp
06/14/2022
 
 
TXT Senate Unveils User Fee Reauthorization Bill With FDA Enhancements
05/27/2022
 
 
TXT Groups Want Stronger Post-Market Trial Enforcement
05/24/2022
 
 
TXT Drug Importation Small Entity Q&A
05/25/2022
 
 
TXT BLOCKING Act Would Hurt Generic Drug Access: Attorneys
05/25/2022
 
 
TXT CDRH Seeks Feedback on eSubmission Process
07/18/2022
 
 
TXT Value Seen in Joint GCP Inspections
05/25/2022
 
 
TXT FDA Denies ICAN Petition on J&J Covid Vaccine
05/26/2022
 
 
TXT FDA ‘Irresponsible’ in NIPT Safety Warning: Attorneys
05/25/2022
 
 
TXT Researchers See Breakthrough Therapy Value in Cancer
05/26/2022
 
 
TXT Amazon Distributing Unapproved New Drugs: FDA
08/09/2022
 
 
TXT FDA Extends Review of Reata Pharma NDA
08/09/2022
 
 
TXT QS, Other Violations at Zyno Medical
08/09/2022
 
 
TXT EUA for Modified Administration of Monkeypox Vaccine
08/09/2022
 
 
TXT Myfembree Wins OK for Endometriosis Pain
08/08/2022
 
 
TXT Appeals Court Overturns Preemption-related Dismissal
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 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 Charles River Wants Endotoxin Assay Regulation
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 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 Share All Cancer Drug Approval Data: Study
07/28/2022
 
 
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 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 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
 
 
 
 
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;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving