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Priority Review for Sanofi’s Efanesoctocog Alfa 08/30/2022

Device Cybersecurity Firm Hires Former FDA Reviewer 08/30/2022

Multiple Violations at Elite One Source 08/30/2022

Lessons Learned from PPI Case Studies 08/30/2022

FDA Introduces Overdose Prevention Framework 08/30/2022

Outlook Resubmits ONS-5010 BLA 08/30/2022

Farxiga Phase 3 Data Show Mortality Benefit 08/29/2022

2 ICH Guidances on Drug Analytical Procedures 08/26/2022

Medtronic HVAD Battery Recall is Class 1 08/25/2022

Novartis Suspends Dosing in Branapalm Trial 08/25/2022

CGMP Violations at Oregon’s Wild Harvest 08/25/2022

Steps Toward Drug Quality Knowledge Management System 08/25/2022

Positive Results in Pfizer RSV Vaccine Trial 08/25/2022

FDA Approves Abbott Proclaim Plus System 08/25/2022

FDA Releases 3 Drug Safety-Related Label Changes 08/24/2022

House Committee on Trump's Covid Pressure on FDA 08/24/2022

Amazon Warning Letter Raises Questions: Attorneys 08/24/2022

Pull IPOL Polio Vaccine Until Better Trial Held: ICAN 08/24/2022

GSK Opposes Teva Coreg ‘Skinny Label’ Appeal 08/23/2022

Stakeholders Want More Drug Shortage Mitigation Info 08/23/2022

Ways to Improve FDA Advisory Committee Process 08/23/2022

FDA Updates eMDR System Enhancements 08/23/2022

MDIC Somatic Reference Samples Initiative 08/23/2022

Califf on FDA and the Clinical Community 08/23/2022

Optical Lens Maker Pays $16.4 Million Over False Claims 08/23/2022

CDER to Discuss Quality Management Maturity at Meeting 08/22/2022

Draft Guide on Charging for Investigational Drugs 08/22/2022

Koag Vascular Closure Pad Cleared 08/22/2022

NIH’s Fauci Stepping Down At End of Year 08/22/2022

Medtronic Defibrillator Recall is Class 1 08/19/2022

FDA Cites Sun Pharma Over GMP Violations 08/19/2022

Draft Guide on Contact Lens Care Labeling 08/18/2022

FDA Lifts 1 Emavusertib Clinical Hold 08/18/2022

FDA Approves Bayer Mirena sNDA 08/18/2022

CDER Working on Pediatric Extrapolation Framework 08/18/2022

Medical Device Recalls Up in 2nd Quarter: Sedgwick 08/18/2022

Radiolabeled Mass Balance Study Comments 08/17/2022

Final Rule on OTC Hearing Aids 08/17/2022

Respironics Ventilator MDRs Increase 08/17/2022

Preceptis Device Cleared for Ear Tube Procedures 08/17/2022

Makena NDA Withdrawal Hearing 10/17-19 08/16/2022

Drug Inspections at ‘Operational Levels’: Throckmorton 08/16/2022

Emergent BioSolutions Warning Letter Out 08/16/2022

Case Safety Report Transmission Guide 08/16/2022

Pharma CEO Pleads Guilty to FDA False Statements 08/15/2022

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

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

Myfembree Wins OK for Endometriosis Pain 08/08/2022

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

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

Charles River Wants Endotoxin Assay Regulation 08/03/2022

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

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

Share All Cancer Drug Approval Data: Study 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

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

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

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

FDA Refusing to Approve ITCA 650 09/02/2021

Uproar Greets FDA’s Aduhelm OK for Alzheimer’s 06/08/2021

CGMP Problems at Catalent Pharma Solutions 04/08/2008

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