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Guidance on ISO-10993-1 Explained 09/21/2023

Ozempic Mental Health Issues Up: NPR 09/21/2023

Merck sBLA for Keytruda Use in Cervical Cancer 09/21/2023

Orphan Drug Designation for Puma’s Alisertib 09/21/2023

FDA Dismisses Novo Nordisk Inspection Concerns 09/21/2023

CRL for ARS Pharmaceuticals’ Neffy 09/20/2023

‘Major Disruption’ Clinical Trial Guidance 09/20/2023

Industry Fights FDA on Drug Shortage Fixes: Califf 09/20/2023

FDA Reviewers Again Nix Intarcia Diabetes Product 09/20/2023

Drug Preemption Defense Demanding, Attainable: Attorneys 09/20/2023

Taysha Discontinues Gene Therapy Program 09/20/2023

UCB Faces Another Review Delay on Bimekizumab 09/20/2023

FDA Recalls Saline Solution 09/20/2023

CGMP, Other Violations at PureChemPros 09/19/2023

Breakthrough for Parkinson’s Neurostimulator 09/19/2023

Kimera Labs Illegally Marketing Exosomes: FDA 09/19/2023

CDRH International Harmonization Plan 09/19/2023

More 510(k) Changes Likely: Attorneys 09/19/2023

FDA Converts ASCA from Pilot to Permanent 09/19/2023

Houston Man Sentenced in Counterfeit Drugs Case 09/19/2023

Vanda Hetlioz Dispute with FDA Heats Up 09/19/2023

English Doctor Attacks FDA/CDC Covid Vaccine Data 09/18/2023

Drug Use-related Software Labeling Guide 09/18/2023

Substantial Evidence from 1 Trial Guidance 09/18/2023

Petition Denied on Tacrolimus Bioequivalence 09/18/2023

Vision Patient-reported Outcomes Workshop 09/18/2023

Novo Nordisk Gets FDA-483: Reports 09/18/2023

FDA OK’s Ferring’s Bladder Cancer Gene Therapy 12/16/2022

Panel to Examine Ongoing Covid Vaccine Modifications 12/16/2022

Contractor Conflict-of Interest Bill Passes Congress 12/16/2022

Aurigene Ditches Psoriasis Drug Candidate 12/16/2022

Providence Medical Tech Cavux Facet Device Cleared 12/16/2022

Draft Guide on Pulmonary Tuberculosis Drugs 12/15/2022

Draft Inspection Refusal Guidance 12/15/2022

FDA Stem Cell Therapy Regulation at Risk: Attorneys 12/15/2022

FDA Updates CRL Guidance Performance Goals 12/15/2022

Comments on Immune-Mediated Adverse Reaction Guidance 12/15/2022

Independent FDA Needed to Stop Political Meddling: GAO 12/15/2022

Harmonize Innovative Manufacturing Regulation: PhRMA 12/14/2022

AdvaMed Supports Breakthrough Device Guidance Updates 12/14/2022

VALID Could Hurt Home Sample Testing: Attorneys 12/14/2022

Former NECC Ops Director Sentenced to 5 Months in Jail 12/14/2022

FDA Panel Thumbs Down on Heart Failure Drug 12/14/2022

States Pushing for Canadian Drug Imports: Report 12/14/2022

FDA Accepts NDA for Eye Dilating Combo Product 12/13/2022

$2.25 mil. RWD Funding Opportunity 12/13/2022

CGMP Deviations Seen in Centrient Inspection 12/13/2022

Clinicians Need Refresher on Clinical Trial Statistics: Survey 12/13/2022

What’s Behind the New LASIK Guidance? 12/13/2022

Assign TE Codes for All Approved Drugs: Study 12/13/2022

Change Antibiotic Development Incentives: Study 12/13/2022

Moderna/Merck Cancer Vaccine Meets Endpoint 12/13/2022

Doc Group Wants FDA Probe of Musk’s Neuralink 12/13/2022

Smiths Device Correction on CADD Infusion System 12/12/2022

CVM Sees 1% Decrease in Food Animal Antimicrobial Use 12/12/2022

Academics Urge FDA to Simplify Breast Density Notifications 12/12/2022

DoJ Indictment on Unapproved Drugs 12/12/2022

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program 12/12/2022

FDA Hits 2 QuVA Pharma Facilities with 483s 12/12/2022

Academics Urge Tougher FDA Stance on Accelerated NDAs 12/09/2022

Device Voluntary Malfunction Summary Reporting Guide 12/09/2022

Remel Recalls Thermo Scientific Sensititre Plates 12/09/2022

Janssen Files BLA for Myeloma Therapy 12/09/2022

2 Roche Alzheimer’s Tests Cleared by FDA 12/09/2022

10 Observations in Aurobindo Unit FDA-483 12/08/2022

Non-Device Software Function Report 12/08/2022

Draft VMSR Guidance for Manufacturers 12/08/2022

16 Observations on Lupin Unit FDA-483 12/08/2022

FDA Proposes More Comprehensive IND Reports 12/08/2022

Draft Device Human Factors Guidance 12/08/2022

Comments on Pediatric Clinical Pharmacology Draft 12/08/2022

FDA Manuscript in the Works on Trial Diversity Strategy 12/08/2022

FDA Denies Homeopathy Petition 12/07/2022

Significant HCT/P Deviations at Cryos International 12/07/2022

FDA Denies Petition on Scrubs as Medical Devices 12/07/2022

PhRMA Issues with FDA Medical Queries 12/07/2022

Device Shortages Need More Transparency: FDA 12/07/2022

Coalition for Health AI Meeting Summary 12/07/2022

FDA Defends Training/Support of Team Biologics 12/07/2022

FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug 12/07/2022

FDA Accelerated Approvals Down This Year: AP 12/07/2022

AG Hair Limited CGMP Issues 12/06/2022

CGMP Violations at Glenmark Pharmaceuticals 12/06/2022

CGMP Violations in Kari Gran Inspection 12/06/2022

FDA Maintains ‘High Bar’ for P13K Inhibitors 12/06/2022

FDA Developed New Covid Drug Surveillance: Study 12/06/2022

Team Biologics Needs More Staff, Training: Former FDAers 12/06/2022

Pass VALID Act Now: Former Commissioners 12/06/2022

Guide on PK-Based Criteria for PD1/PD-L1 Alt Dosing 12/06/2022

Contract Lab Valisure Relinquishes its Testing Prowess 12/06/2022

FDA Updates Endologix Endovascular Graft Safety 12/06/2022

Clinical Hold Issues Outlined for Cholesterol Gene Therapy 12/05/2022

FDA Confirms Survival Rate With Abiomed’s Heart Device 12/05/2022

Firms Seek EUA for Omicron Vaccine in Young Children 12/05/2022

Novartis Seeking Expanded Pluvicto Use 12/05/2022

Guide on ‘Selective’ Drug Safety Data Collection 12/05/2022

Getinge Intra-Aortic Balloon Pumps on Shortage Lis 12/02/2022

Draft Guide on Bioequivalence Statistical Approaches 12/02/2022

Oncologic Drugs Committee Renewed for 2 Years 12/02/2022

Biden Signs Medical Marijuana/Cannabidiol Research Law 12/02/2022

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