FDA Working on Januvia Shortage 08/10/2022

FDA Clears Bodyport Cardiac Fluid Scale 08/09/2022

CorMedix Hit With 2nd Complete Response on DefenCath 08/09/2022

Objectionable Conditions at Valley Biosystems 08/09/2022

Understanding Drug Risks and Benefits in Tweets 08/09/2022

50 NDAs Not Withdrawn Due to Safety/Efficacy: FDA 08/09/2022

Appeals Court Affirms Dismissal of FOIA Case 08/09/2022

FDA Says Haimen Shengbang Container Recall Class 1 08/09/2022

European Data Privacy Law Affects FDA: Attorney 08/09/2022

Reata Faces FDA Efficacy Scrutiny on Omaveloxolone 08/08/2022

Acadia Gets 2nd Complete Response on Alzheimer's Drug 08/05/2022

Woodcock Outlines IT Transformation at FDA 08/04/2022

Resume User Fee Talks: Disease Interests 08/04/2022

Regenxbio to File BLA for Hunter Syndrome Treatment 08/04/2022

Aurobindo Hit with FDA-483 After Inspection 08/04/2022

Data Don't Support Breakthrough for 510(k)s: Attorney 08/03/2022

CGMP and Other Violations at DSP Skin Care 08/02/2022

IND-Exempt BA/BE Study Guidance 08/02/2022

FDA Corrects Notice on ANDA Withdrawals 07/29/2022

Califf Warns on User Fee Layoff Notices in September 07/29/2022

Guide on Disposable Drug Manufacturing Materials 07/29/2022

Omeros Gets Orphan Status for PNH Therapy 07/29/2022

Regulatory Review Period for Acceleron’s Reblozyl 07/29/2022

Siemens Healthineers Angiography System Cleared 07/29/2022

Some UV Wands are Unsafe: FDA 07/28/2022

1st Year Generic Drug Cluster Accomplishments 07/28/2022

Neonatal Study Pharmacology Considerations 07/27/2022

Expanding Use of Remote Regulatory Assessments: Guide 07/22/2022

6 Ways to Improve Trial Diversity 07/21/2022

Pfizer’s Xalkori OK’d for Myofibroblastic Tumors 07/15/2022

Califf on Tweaking Accelerated Approvals, No Big Revamp 06/14/2022

Senate Unveils User Fee Reauthorization Bill With FDA Enhancements 05/27/2022

Groups Want Stronger Post-Market Trial Enforcement 05/24/2022

Drug Importation Small Entity Q&A 05/25/2022

BLOCKING Act Would Hurt Generic Drug Access: Attorneys 05/25/2022

CDRH Seeks Feedback on eSubmission Process 07/18/2022

Value Seen in Joint GCP Inspections 05/25/2022

FDA Denies ICAN Petition on J&J Covid Vaccine 05/26/2022

FDA ‘Irresponsible’ in NIPT Safety Warning: Attorneys 05/25/2022

Researchers See Breakthrough Therapy Value in Cancer 05/26/2022

Amazon Distributing Unapproved New Drugs: FDA 08/09/2022

FDA Extends Review of Reata Pharma NDA 08/09/2022

QS, Other Violations at Zyno Medical 08/09/2022

EUA for Modified Administration of Monkeypox Vaccine 08/09/2022

Myfembree Wins OK for Endometriosis Pain 08/08/2022

Appeals Court Overturns Preemption-related Dismissal 08/08/2022

CDRH Wants Proposals on Device Learning Site Visits 08/05/2022

Humira ‘Patent Thicket’ Case Dismissal Affirmed 08/04/2022

FDA Working to Cut Ethylene Oxide Emissions 08/03/2022

Juvéderm Volux XC Approved for Jawline Shaping 08/03/2022

FDA Approves Cimerli as Generic Lucentis 08/03/2022

Looking at the FDA/Industry ‘Revolving Door’ 08/03/2022

Alnylam Pharmaceuticals Plans NDA for Patisiran 08/03/2022

False Claims Liability for Medical Device Off-Label Use 08/03/2022

Charles River Wants Endotoxin Assay Regulation 08/03/2022

Allarity Refocuses in Response to FDA Comments 08/02/2022

Guide on N-Acetyl-L-Cysteine Enforcement Discretion 08/02/2022

CDRH Still Working on AL/MI Guidance: Attorneys 08/02/2022

Priority Review for Gamida’s Omidubicel 08/02/2022

ImmunityBio Files BLA for Bladder Cancer Therapy 08/01/2022

Hold Lifted on Celyad Oncology CAR T Therapy 08/01/2022

AstraZeneca Scraps Monalizumab Clinical Study 08/01/2022

FTC Endorsement Guides Require Attention: Lawyer 07/29/2022

Opioid Questions Continue to Dog Califf: AP 07/28/2022

3 Lessons Learned from Fosamax ‘Failure-to-Warn’ Case 07/28/2022

Micro-Organospheres Show Cancer Proof of Concept: NCI 07/28/2022

Covidien Recalls Palindrome and Mahurkar Catheters 07/28/2022

Share All Cancer Drug Approval Data: Study 07/28/2022

Lexicon Re-files NDA for Heart Failure Drug 07/27/2022

Cannabis Administration and Opportunity Act 07/27/2022

‘Objectionable Conditions’ in Goodman Eye Center Trial 07/27/2022

Cassava Sciences Under Criminal Investigation: Reuters 07/27/2022

FDA OKs Bavarian Nordic’s Vaccine Facility 07/27/2022

Non-Curative Setting Available Therapy 07/27/2022

Viz.ai Subdural Hemorrhage Detector Cleared 07/27/2022

CGMP Violations in Bi-Coastal Pharma Inspection 07/26/2022

API Deviations Found at Jost Chemical 07/26/2022

Avadel Sues FDA Over Lumryz NDA Delay 07/26/2022

Develop Regulatory Framework for Synthetic Cells: Paper 07/26/2022

FDA Accepts Biogen Tofersen NDA for Rare ALS 07/26/2022

FDA Grants Taiho Oncology Lonsurf Petition 07/26/2022

Many Supplements Stay on Market After FDA Warning 07/26/2022

Biotronik Pays $13 Million Under False Claims Case 07/25/2022

Zipperer Debarred by FDA for 5 Years 07/25/2022

Draft Guide on Real-time Oncology Reviews 07/25/2022

Compliance Extension Date on Unique Device IDs 07/22/2022

FDA Proposes to Move to 12-digit National Drug Codes 07/22/2022

Regulatory Review Didn’t Slow Covid Vaccines: Marks 07/21/2022

BioCircuit Technologies 510(k) for Nerve Tape 07/21/2022

Orange Book Therapeutic Equivalence Guide 07/21/2022

New Renuvion/J-Plasma Handpiece Available: FDA 07/21/2022

Whitmer Wants Mifepristone REMS Lifted 07/21/2022