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FDA OKs Pfizer’s Bosulif for Pediatric CML 09/27/2023

Ileus Added to Ozempic Label Adverse Effects 09/27/2023

Gilead Ends AML Trial of Magrolimab 09/27/2023

Prescription Information Modernization Bill 09/27/2023

Boston Scientific’s AVVIGO+ Guidance Device Cleared 09/27/2023

Peace Wellness Marketing Tissue Products: FDA 09/27/2023

Philips Hid Breathing Machine Complaints: Report 09/27/2023

Nephron Pharma Hit Again with FDA-483 09/27/2023

Device QS Cybersecurity Guidance 09/26/2023

FDA Rejects Anti-Sweating Gel 09/26/2023

FDA Pushing EG, DEG Testing 09/26/2023

Guilty Plea in Adulterated HIV Meds Case 09/26/2023

FDA ‘Cut Corners’ to Approve Hetlioz ANDA: Vanda 09/26/2023

Upcoming CBER Changes Explained 09/26/2023

Drug Use Software Guidance Analyzed by Attorneys 09/26/2023

Novartis Touts Positive Lutathera Phase 3 Data 09/25/2023

FDA Reviewers Dismiss ALS Therapy Benefit 09/25/2023

FDA Clears Profound Medical Ablation Module 09/25/2023

VistaPharm Recalls Sucralfate Lot 09/25/2023

Coherus Gets Complete Response on Udenyca 09/25/2023

Manufacturing Resumes at Damaged Pfizer Site 09/25/2023

FDA Releases Novo Nordisk FDA-483 09/22/2023

Government, FDA Shutdown Appearing More Likely 09/22/2023

Guide on Inspection Alternative Tools 09/22/2023

Senators Urge FDA to Strengthen Opioid Studies 09/22/2023

Legislation Introduced to Improve Device Recalls 09/22/2023

Panel Votes Down Intarcia Diabetes Implant 09/22/2023

PDUFA Formal Meeting Guidance 09/21/2023

Drug Manufacturing Alternative Assessment Tools 09/21/2023

Guidance on ISO-10993-1 Explained 09/21/2023

Ozempic Mental Health Issues Up: NPR 09/21/2023

Merck sBLA for Keytruda Use in Cervical Cancer 09/21/2023

Orphan Drug Designation for Puma’s Alisertib 09/21/2023

FDA Dismisses Novo Nordisk Inspection Concerns 09/21/2023

‘Major Disruption’ Clinical Trial Guidance 09/20/2023

Industry Fights FDA on Drug Shortage Fixes: Califf 09/20/2023

FDA Reviewers Again Nix Intarcia Diabetes Product 09/20/2023

Drug Preemption Defense Demanding, Attainable: Attorneys 09/20/2023

Taysha Discontinues Gene Therapy Program 09/20/2023

UCB Faces Another Review Delay on Bimekizumab 09/20/2023

FDA Recalls Saline Solution 09/20/2023

CRL for ARS Pharmaceuticals’ Neffy 09/20/2023

Kimera Labs Illegally Marketing Exosomes: FDA 09/19/2023

CDRH International Harmonization Plan 09/19/2023

More 510(k) Changes Likely: Attorneys 09/19/2023

FDA Converts ASCA from Pilot to Permanent 09/19/2023

Houston Man Sentenced in Counterfeit Drugs Case 09/19/2023

Vanda Hetlioz Dispute with FDA Heats Up 09/19/2023

CGMP, Other Violations at PureChemPros 09/19/2023

Breakthrough for Parkinson’s Neurostimulator 09/19/2023

English Doctor Attacks FDA/CDC Covid Vaccine Data 09/18/2023

Drug Use-related Software Labeling Guide 09/18/2023

Substantial Evidence from 1 Trial Guidance 09/18/2023

Petition Denied on Tacrolimus Bioequivalence 09/18/2023

Vision Patient-reported Outcomes Workshop 09/18/2023

Novo Nordisk Gets FDA-483: Reports 09/18/2023

FDA Extends BLA Review of Melanoma Therapy 09/15/2023

Digital Health Frequently Asked Questions 09/15/2023

Beacon Biosignals 510(k) for Sleep Monitor 09/15/2023

FDA OKs GSK’s Blood Cancer Drug 09/15/2023

Draft Guide on Biosimilar/Interchangeable Labeling 09/15/2023

Voluntary Improvement Program Guidance 09/14/2023

Breakthrough Devices Updated Final Guidance 09/14/2023

Forms FDA 3988 and 3989 Guidance 09/14/2023

AI is FDA Info Technology Plan’s Top Goal 09/14/2023

FDA 2 Weight Loss Device Guidances 09/14/2023

FTC Warns on Improper Orange Book Patent Listings 09/14/2023

FDA Clarifies Safety of Phenylephrine Products 09/14/2023

FDA, Rocket Agree on Phase 2 Danon Disease Trial 09/13/2023

Safety Concerns Stop Eiger Phase 3 Hepatitis Trial 09/13/2023

Supremes May Hear Label Preemption Case: Attorneys 09/13/2023

Include ICH Q12 in Gene Therapy Guidance: ISPE 09/13/2023

White House Credits FDA on Drug Shortages 09/13/2023

Abbott Recalls Proclaim Pulse Generators 09/13/2023

‘Good Cause’ Guidance Needs Flexibility: PhRMA 09/13/2023

Bipartisan Legislation on Patent Listings 09/13/2023

FDA Questions Efficacy of Patisiran sNDA 09/12/2023

FY 2022 GDUFA Science, Research Outcomes 09/12/2023

Safecor Health CGMP Violations 09/12/2023

Similasan Marketing Unapproved New Drugs: FDA 09/12/2023

FDA Warns 8 Firms for Unapproved Eye Drugs 09/12/2023

CDER Defends Pepaxto Withdrawal Proposal 09/12/2023

2 FDA Recommendations in Patient Safety Report 09/12/2023

White Paper on Preventing Drug Shortages 09/12/2023

Panel Votes Down OTC Cold Ingredient 09/12/2023

Mallinckrodt Recalls One-Way Ventilator Valve 09/12/2023

Jury Convicts 2 for Clinical Trial Fraud 09/12/2023

FDA Permanently Debarring Tatsene 09/12/2023

45 Device Alerts Issued in 2022: FDA 09/11/2023

Justice Petitions Supreme Court Over Mifeprex 09/11/2023

Updated Covid-19 Vaccines Approved by FDA 09/11/2023

Tagrisso Phase 3 Data in Lung Cancer 09/11/2023

Guide on Peptide Clin-Pharm Considerations 09/11/2023

CMC Readiness Pilot Program 09/11/2023

Novartis Recalls Sandimmune Lot 09/11/2023

FDA Updates Alert on Halyard N95 Masks 09/08/2023

Senators Reintroduce Opioid Studies Bill 09/08/2023

House Committee Hearing on Drug Shortages 09/08/2023

Subcutaneous Tecentrig Delayed Due to CMC Info 09/08/2023

GAO Report Probes Device DTC Advertising 09/08/2023

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