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Suggestions for Biosimilar Research Roadmap 04/11/2023

CGMP Issues at India’s Champaklal Pharmacy 04/11/2023

Improve ICH M13A Bioequivalence Guidance: PhRMA 04/11/2023

FDA Launching Patient Guidance Snapshots 04/11/2023

Health Misinformation Hurts Life Expectancy: Califf 04/11/2023

New FDA Cybersecurity Safeguard Requirements 04/11/2023

Companies Not Ready for New Cyber Safeguards: Article 04/11/2023

FDA Sets Device Radiation Sterilization File Pilot 04/11/2023

Regulatory Reforms Needed for AI Devices: Shuren 04/11/2023

Mifeprex Judge Damns FDA for Worse Abortion Outcomes 04/10/2023

What of FDA’s Gold Standard After Kacsmaryk? 04/10/2023

Panel to Mull Leqembi Confirmatory Study 04/10/2023

Sarepta Duchenne BLA Heads to Panel 04/10/2023

Reach Neuro Wins ‘Breakthrough’ for Stroke Stimulator 04/10/2023

DoJ Formally Appeals Mifepristone Texas Order 04/10/2023

Merck, Eisai Discontinue Melanoma Trial 04/10/2023

Horizon Therapeutics Touts Thyroid Eye Disease Data 04/10/2023

Phillips Recalls DreamStation Breathing Devices 04/07/2023

Two Imbruvica Accelerated Approvals Withdrawn 04/07/2023

Rep. Kim Reintroduces Drug Recall Authority Bill 04/07/2023

Florida Gets $600K in Cochlear Implants Case 04/07/2023

FDA Explores AI Image Analysis for Complex Drugs 04/07/2023

Boost Faith in Accelerated Approvals: Researchers 04/06/2023

RSVpreF Vaccine Meets Endpoints 04/06/2023

Mutagenic Impurities Guideline Adopted 04/06/2023

FDA Wants MDUFA 5 PPI Input 04/06/2023

FDA Pulls Makena Approval Immediately 04/06/2023

FDA Clears restor3D 510(k) for Ankle Device 04/06/2023

2 Texas Men Plead Guilty to Misbranded Drug Sales 04/06/2023

Endpoint Clinical Outcome Assessment Guidance 04/05/2023

3 Ex-Magellan Officials Charged Over Device Malfunctions 04/05/2023

Multiple Violations in Aspire Pharma Inspection 04/05/2023

Withdraw Wakix Approval: Scorpion Capital Petition 04/05/2023

Lab Tests Could be in Preparedness Bill 04/05/2023

QuVa Pharma FDA-483 04/05/2023

CDER is in Growth Mode from Hiring Spree: Cavazzoni 04/05/2023

FDA on Pharmacodynamic Biomarker Research 04/04/2023

Docket Open for Opioids Home Disposal REMS 04/04/2023

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

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