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Chimerix Plans Accelerated Approval NDA for Gliomas Drug 12/09/2024

Fresenius Hit With 11-Item FDA-483 12/09/2024

e-Submission Guide for BIMO Inspection Planning 12/06/2024

Panel to Discuss Opioid Abuse Studies 12/06/2024

Drug/Biologic Accelerated Approval Draft Guide 12/06/2024

GE Healthcare Recalls Newborn Incubators 12/06/2024

Groups Urge Rare Disease Voucher Reauthorization 12/06/2024

FDA Loses Again in FOIA Suit on Vaccine Records 12/06/2024

Syndax Leukemia Review Extended by FDA 07/29/2024

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2 Imbruvica Accelerated Approvals Withdrawn 12/17/2023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

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

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

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

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

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

Cardinal Health Recalls Procedure Kits 12/08/2023

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

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

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

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

Restrict ANDAs for Generic Zoryve: Arcutis 12/06/2023

eSTAR e-Submissions Open for PMAs 12/06/2023

CBER Helping to Speed Gene Therapies: Marks 12/06/2023

Opdivo sBLA for Bladder Cancer 12/06/2023

Animal Drug Regulations Amended 12/06/2023

Industry Concerns with Predicate Device Guide 12/06/2023

Review Extended on Sinus Drug 12/06/2023

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

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

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

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

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

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

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

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