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FDA Selecting Fall Covid Vaccine Make-up in June 04/04/2023

OCP IND Prioritization, Triage Guidance 04/04/2023

Guide on Animal Drug Human Safety Assessments 04/04/2023

Abbott Safety Notice on FreeStyle Libre Readers 04/04/2023

Tavo-EP/Keytruda Fails Phase 2 Melanoma Trial 04/04/2023

Synovo Adulterated, Misbranded Products 04/04/2023

FDA ‘Consistent’ in Implementing NME Communications 04/04/2023

EUA for Gohibic for Some Hospitalized Covid Patients 04/04/2023

BC3 Tech Clears SEAL Rapid Wound Spray 04/03/2023

Opioid Makers Must Provide Mail-back Envelope 04/03/2023

Untitled Letter to Minneapolis Regenerative Medicine 04/03/2023

Deficiencies Found in Ascendis Pharma NDA: FDA 04/03/2023

54% of Confirmatory Studies Are Late Meeting Deadlines 04/03/2023

Guide on Harmonized Medicinal Product Identification 03/31/2023

U.S. Government Sides with Generics in Labeling Case 03/31/2023

Datascope Recalls Cardiosave and Hybrid Pumps 03/31/2023

FDA Hits India Drug Maker with 14-page 483 03/31/2023

Bill Would Prevent ANDA Blocking on 1st Generics 03/31/2023

FDA Evaluating Adult Dental Device Concerns 03/30/2023

Midwest Vet Supply Forfeits $10 Million for Misbranding 03/30/2023

AI/ML Software Marketing Submission Guidance 03/30/2023

VALID Act Reintroduced 03/30/2023

Research on Some Child Subjects Guidance 03/30/2023

Align Global Gene, Cell Therapy Regulation: Marks 03/30/2023

FDA Converts 1 Keytruda Indication to Full Approval 03/30/2023

Califf Says GOP Budget Cuts Would Devastate FDA 03/30/2023

Device Cybersecurity Enforcement Discretion 03/29/2023

‘Objectionable Conditions’ in Med School Pediatric Trials 03/29/2023

AI/ML Proliferation Leading to Many Issues: Attorney 03/29/2023

FDA, Alliance Launch Lupus ABC 03/29/2023

Emergent Bio Gains OTC Approval of Narcan Spray 03/29/2023

FDA Shifting Accelerated Approval Approach: Attorneys 03/29/2023

Non-Spinal Orthopedic Plate 510(k) Guidance 03/28/2023

Court Orders Release of FDA Vanda Info 03/28/2023

IND Not Submitted for Cornea Associates Trials: FDA 03/28/2023

House Committee Questions FDA Drug Shortage Actions 03/28/2023

Guide on Animal Studies for Devices 03/28/2023

Cell, Gene Therapy Application Backlog Questioned 03/28/2023

Bipartisan Bill on Interchangeable Biologics 03/28/2023

Labeling Changes Approved for 2 Hedgehog Inhibitors 03/28/2023

Guide on Animal Studies for Devices 03/27/2023

Under Protest, Brainstorm Resubmits BLA for NurOwn 03/27/2023

FDA Resumes Generic Drug In-person Meetings 03/27/2023

Alternative 510(k) Pathway for Contact Lenses 03/27/2023

Iovance Biotherapeutics BLA for Melanoma Therapy 03/27/2023

Two Final Guides on Covid-19 Device Transition 03/24/2023

Accelerated Approval Guide Pushes Randomized Trials 03/24/2023

FDA Keeping Close Eye on Social Media Promotion 03/24/2023

New CDRH Web Page on Diagnostic Data Program 03/24/2023

Panel Backs Accelerated OK Consideration of Biogen's ALS Drug 03/23/2023

FDA Digital Health Technologies Framework 03/23/2023

Xtrava Covid Test Less Effective with Some Variants: FDA 03/23/2023

Unibody Endografts Don’t Beat Older Ones: Study 03/23/2023

FDA Reminds on Recalled Exactech Joint Devices 03/23/2023

Dupixent Meets Key Phase 3 Endpoints: Regeneron 03/23/2023

Workforce, Education for Regenerative Medicine 03/23/2023

OSTP Goals for Biotechnology and Biomanufacturing 03/23/2023

Device Cybersecurity is Top Concern for Shuren 03/23/2023

Consider Antitrust in Apokyn Generic Case: FTC 03/22/2023

Complete Response for AbbVie Parkinson’s NDA 03/22/2023

Registry Set Up for Breast Implant Carcinoma Reports 03/22/2023

Contradictory Info in P&G Nyquil Filing: FDA 03/22/2023

Steps Needed to Address Drug Shortages: Report 03/22/2023

Ways to Increase Clinical Trial Diversity: PhRMA 03/22/2023

Roche/Lilly Collaborate on Alzheimer’s Test 03/22/2023

Biological Product Deviation Reports Up: CBER 03/22/2023

Regulators Need to Keep Up with ‘Patient Influencers’: Study 03/22/2023

Sandoz sBLA for Citrate-free Hyrimoz 03/21/2023

ICH Approves Gene Therapy S12 Guidance 03/21/2023

Changes Suggested for Cancer Drug Dosing Guidance 03/21/2023

‘Significant’ CGMP Violations at Dunagin Pharmaceuticals 03/21/2023

Multiple Violations at Contract Manufacturer 03/21/2023

Turn Gene Therapy into Reality: Marks 03/21/2023

CDER’s Requests for Intarcia Hearing 03/21/2023

Drug Promotion Research Landscape Analyzed 03/21/2023

Brainomix AI Stroke Tool Cleared by FDA 03/21/2023

Viz.ai Algorithm Cleared for Abdominal Aneurysms 03/21/2023

Guide on Pharmacogenomic Data Submissions 03/20/2023

FDA Input on Rare Disease Development Needed: PhRMA 03/20/2023

Keep Device Real-World Evidence Under NESTcc: MDMA 03/20/2023

Athenex Cell Therapy on Clinical Hold 03/20/2023

Remote Assessments May Be Model for Device Inspections 03/20/2023

Accelerated Approval Mulled for Biogen’s Tofersen 03/20/2023

Ipsen NDA Resubmission for Palovarotene 03/17/2023

Sarepta BLA Needs Panel Review: FDA 03/17/2023

Guide on Pharmacogenomic Data Submissions 03/17/2023

FDA Hits Olympus with Warning Letter 03/17/2023

CDER Posts Annual Office of Compliance Report 03/17/2023

Datascope’s Cardiosave Heart Pumps Recalled 03/17/2023

Medical Foods Q&A Guidance 03/16/2023

Drug Supply Guide on Illegitimate/Suspect Products 03/16/2023

FDA Clears BD Vaginitis Test 03/16/2023

Glaxo MenABCWY Vaccine Hits 11 Endpoints 03/16/2023

IPRP Cell/Gene Therapy Raw Materials Paper 03/16/2023

Senate Appropriators Announce 4/19 FDA Budget Hearing 03/16/2023

Panel Votes to Support Paxlovid NDA Approval 03/16/2023

Community Should Push AA Drug Studies: Califf 03/16/2023

PhRMA Comments on Drug Labeling Guidance 03/15/2023

Janssen Vaccine Warning on Myocarditis/Pericarditis 03/15/2023

FDA Clears Telehealth Respiratory Wheeze Detector 03/15/2023

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