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Eisai sBLA for Monthly Alzheimer’s Maintenance 04/01/2024

FDA Guide on Safety Report e-Submissions 04/01/2024

FDA Clears Abbott’s Concussion Blood Test 04/01/2024

PhRMA Seeks Specificity for Cell Product Potency Guide 04/01/2024

Guide on Dental Bone Grafting Devices 03/29/2024

Thoratec Recalls HeartMate Touch Communication 03/29/2024

eSTAR Now Available for Device 513(g) Requests 03/29/2024

ProJenX Partial Hold Lifted in ALS Study 03/29/2024

Poll Backs FDA Status Quo in Approving Products 03/29/2024

Guidance on IND Safety Report eSubmissions 03/29/2024

Review Extended on Govorestat NDA 03/29/2024

Dental Bone Graft Animal Study Guide 03/28/2024

FDA Approves Akebia Vafseo for Some Anemias 03/28/2024

Aldeyra Plans for Reproxalap NDA Resubmission 03/28/2024

3-year-old Fusion IV FDA-483 Released 03/28/2024

ASCA Pilot Met, Exceeded Expectations: CDRH 03/28/2024

Amneal Recalls 4 Lots of Vancomycin 03/28/2024

FDA OKs Expanded Use for Hepatitis B Drug 03/28/2024

Medexus’ Hemophilia B Factor Gets Expanded Use 03/28/2024

2 REMS Assessment MAPPs 03/27/2024

FDA ‘Fails to Follow Science’ in Electroshock Case: Attorneys 03/27/2024

BIO Suggestions for CGT Potency Guidance 03/27/2024

Catalent Indiana FDA-483 03/27/2024

Merck BLA for Winrevair Approved 03/27/2024

Proposed Ban on Certain e-Stimulation Devices 03/27/2024

Weiner Moves to Foreign Inspections Office 03/27/2024

Boston Scientific Recalls PolarSheath Steerable 03/27/2024

FDA Approves Medtronic Evolut FX+ 03/27/2024

CGMP Violations at Deqing Jiarou 03/26/2024

Multiple Violations in ReNovo Inspection 03/26/2024

Rep. Questions Musk Device Trial OK Before Inspection 03/26/2024

Antibody Drug Conjugate Guidance Explained 03/26/2024

High Court Skeptical on Mifepristone Restrictions 03/26/2024

Clinical Data Interchange Standards Update 03/26/2024

Revised BA/BE Sample Handling Guidance 03/26/2024

Bioresearch Monitoring Issues at New York Site 03/26/2024

Mesoblast Refiling BLA for Remestemcel-L 03/26/2024

NEWSROOM CLOSED FOR THE HOLIDAYS 12/18/2023

FDA OKs Merck Kidney Cancer Drug 12/17/2023

FDA OKs Glaukos Intraocular Pressure Drug Implant 12/17/2023

2 Imbruvica Accelerated Approvals Withdrawn 12/17/2023

DTC Survey Examines Quantitative Claims 12/17/2023

FDA Updates Breast Implant Safety Info 12/17/2023

Guide on Priority Zoonotic Animal Drugs 12/17/2023

Moderna Inspection Cites GMP Issues: Report 12/17/2023

FDA Warns Makers of Illegal Animal Antimicrobials 12/14/2023

FDA in 3 More Collaborative Communities 12/14/2023

House Committee Threatens FDA Subpoena 12/14/2023

FDA ‘Doing Little’ on Social Media Drug Claims: Report 12/14/2023

Pharmasol Permanent Injunction Approved 12/14/2023

Clinical Hold on 3 CARsgen CAR T-cell Therapies 12/14/2023

Stakeholder Technical Issues with Ophthalmic Guide 12/14/2023

FDA Approves Neuroblastoma Drug 12/14/2023

Update GAO Device Recall Oversight Report: Senators 12/13/2023

Novid Distributing Unapproved, Misbranded Drug: FDA 12/13/2023

Guide on Advanced Manufacturing Tech 12/13/2023

Regulatory Affairs, Foods Program Under Review 12/13/2023

HELP Committee OKs EFFECTIVE Opioid Bill 12/13/2023

GOP Senators Urge Increase in Foreign Inspections 12/13/2023

Amgen Files Priority BLA for Lung Cancer 12/13/2023

AdvaMed Faults FDA on ‘Safety’ 510(k) Guidances 12/13/2023

Supreme Court Agrees to Hear Mifepristone Case 12/13/2023

First Psychedelic NDA Filing Claimed for PTSD Therapy 12/12/2023

New Genetic Metabolic Disease Treatment A/C 12/12/2023

Strengthen Botox Safety Warning: Public Citizen 12/12/2023

Advanced Manufacturing Technologies Guidance 12/12/2023

Dolor Tech Settles Over Migraine Device 12/12/2023

Peptide Clinical Pharmacology Guidance 12/12/2023

Risk-Based Approach to Therapeutic Protein DDI 12/12/2023

CDISC Study Tabulation Model Version 3.4 12/12/2023

FDA May Not be Ready for LDT Rule: Attorney 12/12/2023

Oncology Drug Dose Optimization Often Deferred: Analysis 12/12/2023

Guide on DTC Quantitative Efficacy/Risk Info 12/11/2023

Device CEO Pleads Guilty in Covid Test Scheme 12/11/2023

FDA Requiring Less Burdensome Isotretinoin REMS 12/11/2023

NDA Resubmission on Hypoparathyroidism Accepted 12/11/2023

PETA Letter Hits at FDA Lab Animal 'Cruelty' 12/11/2023

Pfizer BLA for Hemophilia Accepted for Review 12/11/2023

Trump Aligned Group Sues FDA on Ivermectin 12/11/2023

Cardinal Health Recalls Procedure Kits 12/08/2023

First Sickel Cell Gene Therapies Approved 12/08/2023

Novartis Reports Risk Reduction Kisqali Data 12/08/2023

Guide on Drug Supply Chain Security 12/08/2023

Getinge Recalls CardioHelp Emergency Drive 12/08/2023

Info Collection on OTC Drugs 12/08/2023

Alpha Cognition NDA for Alzheimer’s Filed 12/07/2023

Positive Phase 1/2 Linvoseltamab Results to FDA 12/07/2023

Pediatric Drug Development Bill Introduced 12/07/2023

Action Against BPI Methylene Blue Injection Asked 12/07/2023

Restrict ANDAs for Generic Xipere: Bausch & Lomb 12/07/2023

Merck Halts Keytruda Lung Cancer Trial 12/07/2023

Pro Publica Slams FDA on Respirator Recall 12/07/2023

Section 503B Compounding Enforcement Discretion 12/07/2023

FDA Clears BD ‘Novel’ Blood Sampler 12/07/2023

Bill to Establish HHS Generic Drug Manufacturer 12/07/2023

Review Extended on Sinus Drug 12/06/2023

FDA Sets Bulk Substance Compounding Policy 12/06/2023

FDA Grants, Denies Provepharm ProvayBlue Petition 12/06/2023

Novartis’ Fabhalta for PNH Approved 12/06/2023

Probe FDA ‘Cozy Relationship’ with Pharma: Rep. Harris 12/06/2023

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