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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

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

Oncology Center Pact on Real-world Evidence 12/05/2023

Belmont Eyecare Selling Unapproved Eye Drops: FDA 12/05/2023

MONARCH 3 Results Show Verzenio Success: Lilly 12/05/2023

How FDA ‘One-stop’ PJOs Help Combo Industry 12/05/2023

No Safety Issues in Biosimilar Switches: CDER Research 12/05/2023

Pentagon Hits FDA on Generic Testing 12/05/2023

FDA Releases Novartis Untitled Letter on GMPs 12/05/2023

ABK Biomedical Gets Breakthrough Status 12/05/2023

FDA Urges ClinicalTrials.gov Compliance 12/04/2023

Lilly’s Jaypirca Gains OK in Leukemia/Lymphoma 12/04/2023

Pressing Need for Alternative Inspections: Researchers 12/04/2023

J&J Breakthrough Status on Bladder Cancer Drug 12/04/2023

Lawmakers Press Califf on OTC Decongestant 12/04/2023

West Pharma Vial2Bag Admixture Device Cleared 12/04/2023

CDER Cleaning House on Dormant Petitions 12/01/2023

Eitan Medical Recall Infusion Pumps 12/01/2023

Info Collection Extension on Orphan Drugs 12/01/2023

Twice-Daily Weight Loss Drug Stalls: Pfizer 12/01/2023

Epcoritamab Breakthrough Status in Follicular Lymphoma 12/01/2023

BD Recalls Pumps Over Syringe Incompatibility 12/01/2023

FDA Checking Chinese Syringe Safety 11/30/2023

Chief Scientist Tapped as Woodcock Replacement 11/30/2023

More Novo Nordisk Semaglutide Legal Actions 11/30/2023

AbbVie Seeks Accelerated OK for Lung Cancer Drug 11/30/2023

UCB on Pregnancy Safety Studies 11/30/2023

FDA Clears GE Critical Care Suite 2.1 11/30/2023

FDA Fast Track for eFFECTOR’s Zotatifin 11/30/2023

AdvaMed Comments on Electronic Submission Guide 11/29/2023

Concerns About FDA QMM Program 11/29/2023

Durbin, Grassley Push Drug Ad Transparency Bill 11/29/2023

FDA Opens Drug Supply Chain Security Act Portal 11/29/2023

FDA Denies Apixaban ANDA Petition for Safety 11/29/2023

SCA Pharma Issued 10-Item FDA-483 11/29/2023

Karuna NDA for Schizophrenia Accepted by FDA 11/29/2023

Praise for Graft-Versus-Host Drug Guidance 11/29/2023

FDA Studies Nasal Spray Distribution 11/29/2023

FDA Still Evaluating Left Atrial Occlusion Implants 11/29/2023

New Theories of False Claims Act Liability 11/29/2023

Regenerative Medicine Consensus Standards Guide 11/28/2023

‘Similar’ Intas CGMP Violations 11/28/2023

Korsuva Regulatory Review Period 11/28/2023

Cosela Regulatory Review Period 11/28/2023

Serious Reaction to Some Anti-Seizure Meds: FDA 11/28/2023

Acelyrin Auditing Izokibep Trial Issues 11/28/2023

Dr. Berne’s Selling Unapproved, Adulterated Eye Drops 11/28/2023

Malignancy Events with CAR T-Cell Therapies: FDA 11/28/2023

FDA Warns on Overheating Philips CPAP Devices 11/28/2023

Biden to use Defense Production Act on Shortages 11/28/2023

‘Mixed Reality Device’ CGMP Inspection Success 11/28/2023

Aldeyra Complete Response on Dry Eye NDA 11/27/2023

Novartis Recalls 2 Sandimmune Lots 11/27/2023

FDA Withdraws From Device Harmonization Group 11/27/2023

Priority Review for Abeona Therapeutics BLA 11/27/2023

Entrada Therapeutics’ DMD Drug Remains on Hold 11/22/2023

Covid-19 Treatment, Prevention Products Guidance 11/22/2023

Guide on GLP Study Translation 11/22/2023

FDA Declines to Ban Some Music in DTC Ads 11/22/2023

Masimo Medical Watch Cleared by FDA 11/22/2023

VAERS Has ‘A Proven Track Record’: FDA/CDC 11/22/2023

SCOTUS Should Hear Mifepristone Appeal: FDA 11/22/2023

‘Objectionable Conditions’ in 2 Clinical Trials 11/21/2023

Do Postmarket Studies Need Public Funds?: Califf 11/21/2023

Senators Want Animal Testing Info 11/21/2023

Chinese National Indicted Over Illegal Devices 11/21/2023

GLP Report Translation Q&A Guidance 11/21/2023

Concerns Over FDA Biosimilar Labeling Draft Guide 11/21/2023

Repeat CGMP Violations at Cipla Plant 11/21/2023

Study New Guide on Science Info for MDs: Attorneys 11/21/2023

Abecma Review Delayed for Panel Input 11/20/2023

Info Sought on Supply Chain Security 11/20/2023

Final Rule on DTC Ads’ Major Statements 11/20/2023

Bayer Stops Stroke Drug Study Over Inferiority 11/20/2023

FDA Warns on Monoject Syringes 11/20/2023

Janssen Seeks Expanded Rybrevant Use 11/20/2023

Medtronic’s Symplicity for Hypertension Approved 11/20/2023

Dr. Reddy’s Issued 10-item FDA-483 11/17/2023

FDA OKs AstraZeneca Breast Cancer Drug 11/17/2023

Merck’s Keytruda Gains OK in Gastric Cancer 11/17/2023

Asensus Surgical Recalls Robot Devices 11/17/2023

Device Discontinuance and 506J List Guidances 11/16/2023

FDA Publishes 40 Product-Specific Guidances 11/16/2023

Device Computational Modeling Credibility Guide 11/16/2023

U.S. Drug Shortages Increasing: Report 11/16/2023

Provide Covid Therapeutics Distribution Info: Califf 11/16/2023

Janet Woodcock Retiring in Early 2024 11/16/2023

Managing Legacy Device Cyber Risks 11/16/2023

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