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Updated ICH Good Clinical Practice Guidance 06/06/2023

Multiple Violations at Steiner Biotechnology 06/06/2023

iRhythm Technologies Cited for Unapproved Device 06/06/2023

Norwich Sues FDA Over Rifaximin ANDA 06/06/2023

FDAers Assess Frontline Renal Cancer Treatments 06/06/2023

Sun Pharma India Facility on Import Alert 06/06/2023

FDA Struggles to Recruit in Wake of Retirements 06/06/2023

Abiomed Recalls Impella Heart Pump 06/05/2023

FDA on Pneumatic Tourniquet Cuff Shortage 06/05/2023

FDA Lifts Hold on Foghorn Leukemia Drug 06/05/2023

Draeger Recalls Ventilator Sets/Tubing 06/05/2023

Intas Pharma on Import Alert After Inspection 06/05/2023

Guidance on ANDA Cover Letter Attachments 06/05/2023

FDA Lifts Hold on Multiple Myeloma Drug 06/02/2023

Durbin Urges FDA to Act More on Cancer Drug Shortage 06/02/2023

Therapeutic Protein Drug Interaction Assessment Guide 06/02/2023

Guidance on Device Pre-Submission Meetings 06/02/2023

Interstitial Cystitis/Bladder Pain Syndrome Guidance 06/02/2023

FDA Withdraws 8 No-Longer-Marketed ANDAs 06/01/2023

FDA OKs Pfizer Abrysvo RSV Vaccine 06/01/2023

Migraine Drug Development Guidance 06/01/2023

AstraZeneca Ends Brazikumab Development 06/01/2023

Balance AI Optimism and Pessimism: Califf 06/01/2023

Roche/Genentech Suggestions for nAMD Guidance 06/01/2023

Patient Access to At-Home Technologies 06/01/2023

Doc Bought Oncology Meds to Sell for Profit: DoJ 06/01/2023

FDA Clears Ezra Flash AI for MRI Quality 06/01/2023

CDER Drug Policy Guru Heads to Morgan Lewis 06/01/2023

Clinical Hold on PepGen IND Application 05/31/2023

Precision BioSciences to Meet with FDA on Azer-Cel 05/31/2023

Groups Want Regulation of Lab-Developed Tests 05/31/2023

Junshi Bio Inspection to Advance Toripalimab BLA 05/31/2023

FDA to Permit In-Person End-of-Phase 2 Meetings 05/31/2023

FDA Alert on Compounded Semaglutide 05/31/2023

CDER Risk, Safety Report for 2022 Issued 05/31/2023

FDA Limited in Managing Drug Shortages: Pazdur 05/31/2023

FDA Proposes 1-Page Patient Medication Information 05/30/2023

Violations at Advanced Compounding Solutions 05/30/2023

Priority Review for BMS Lung Cancer Drug 05/30/2023

Concerns with Macular Degeneration Guidance 05/30/2023

Janssen NDA for Pulmonary Hypertension Drug 05/30/2023

Think Surgical Gains Clearance for TMINI Robot 05/30/2023

Pfizer’s Marstacimab Meets Phase 3 Goals 05/30/2023

Akebia Therapeutics Resubmitting Anemia NDA 05/30/2023

Suggestions for Oncology Accelerated Approval Guidance 05/30/2023

iRhythm Gets Warning Letter on Heart Monitor 05/30/2023

BMS Breyanzi ‘Deep and Durable Efficacy’ 05/26/2023

Progression-Free Survival Improves in DUO-E Trial: AZ 05/26/2023

3 Observations in UCB Pharma FDA-483 05/26/2023

Updated Boxed Warning for Rx Stimulants 05/26/2023

Comments on Gene, Cell Therapy Surveillance 05/26/2023

Colorectal Cancer NDA Gets Priority Review 05/26/2023

Neuralink Says FDA OKs Brain Implant Trial 05/26/2023

Sitravatinib Fails in Phase 3 Lung Cancer Study 05/25/2023

Power Morcellation Tissue Containment Guidance 05/25/2023

Trial Covariate Adjustment Guidance 05/25/2023

Drug, Medical Device Recalls Up in 1st Quarter 05/25/2023

Act on Cancer Chemo Shortages: Michigan Reps 05/25/2023

Pfizer Paxlovid NDA Approved for Covid 05/25/2023

Regenerelle Marketing Unapproved HCT/P Products: FDA 05/25/2023

Integra Recalls Products Over Endotoxin Testing 05/25/2023

Phathom Resubmits Vonoprazan NDA 05/24/2023

Generally Accepted Scientific Knowledge Guidance 05/24/2023

FDA Extends Review of Sarepta Gene Therapy 05/24/2023

Tox Study Whole Slide Imaging Guidance 05/24/2023

FDA Wants Comments on REMS Vendor Changes 05/24/2023

ICH Good Clinical Practice Guide Comments 05/24/2023

FDA Seeks Contractors for Drug Performance Automation 05/24/2023

FDA Warns India Pharmacy Over Unapproved Drugs 05/24/2023

SD Biosensor Recalls Contaminated Covid Tests 05/24/2023

Call Out Lawyer Client-Seeking Ads: Petition 05/24/2023

Ex-FDAer Schiller on Accelerated Approval Guide 05/23/2023

Melanoma Imaging Device Get Breakthrough Status 05/23/2023

Lawyer’s Motion to Remain Anonymous Granted 05/23/2023

FDA OK’s New Opioid Use Disorder Option 05/23/2023

Abbott Touts Data on Dual Chamber Pacemaker 05/23/2023

FDA Approval Reciprocity Bill Reintroduced 05/23/2023

FDA Denies Petition for PPI Pneumonia Warning 05/23/2023

Contract Testing Lab Gets Warning Letter 05/23/2023

New FDA MOU for Distributed Manufacturing 05/23/2023

Figures in Tellus Clinical Trial Fraud Case Acquitted 05/23/2023

Petition for Warning on Diabetes Drugs Denied 05/22/2023

CDRH Portal Expanded to Pre-Submission Feedback 05/22/2023

Novo Nordisk Plans NDA for Oral Obesity Drug 05/22/2023

Rain Oncology Scraps Milademetan 05/22/2023

FDA OKs Opiant Pharma’s Opioid Overdose Spray 05/22/2023

FDA Issues 483 to Aurobindo API Facility 05/19/2023

DTC Research Supports Disclosures on Endpoint Differentiation 05/19/2023

Abiomed Recalls Impella 5.5. Blood Pump 05/19/2023

Zoll Settles Case Against China-made ECG Cables 05/19/2023

Topical Gene Therapy for Wounds Approved 05/19/2023

‘Bionic Pancreas’ Cleared by FDA 05/19/2023

Revoke Approval for MSN’s Generic Hetlioz: Vanda 05/18/2023

Nephron Pharmaceuticals Warehouse FDA-483 05/18/2023

AbbVie Gets Rinvoq OK for Crohn’s 05/18/2023

Draeger Recalls Seattle CPAP Device and Components 05/18/2023

Child Cancer Research Bill Reintroduced 05/18/2023

House Dems Working on Cancer Drug Shortage 05/18/2023

Appropriators Cut FDA Budget by $600 million 05/18/2023

Panel Backs Pfizer’s RSV Vaccine 05/18/2023

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