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Class 1 Recall of Medtronic ‘Leaky’ Catheters 01/30/2023

Guide on Acromegaly Drug Development 01/30/2023

Consent Decree Against LGM Pharma 01/30/2023

CDER/CBER Restarting In-Person Industry Meetings 01/30/2023

Oracle Technology Guru Named FDA Digital Health Director 01/30/2023

Lawsuit Against FDA and Livestock/Poultry Antibiotic Use 01/27/2023

FDA Funding Opportunity for Pediatric Device Consortia 01/27/2023

New Data Support Carvykti sNDA in Multiple Myeloma 01/27/2023

Vanda Petitions FDA Over Teva ‘Non-Braille’Labeling 01/27/2023

FDA Denies Petition on Jakafi Safety Labeling 01/27/2023

Eschoo Reelected as Ranking Dem on Health Subcommittee 01/27/2023

LivaNova Again Recalls LifeSPARC Controller Over Software 01/27/2023

Rep. Guthrie to Chair FDA Oversight Committee 01/26/2023

FDORA Requires Trial Diversity Action Plans: Attorneys 01/26/2023

New CBD Regulatory Framework Needed: Woodcock 01/26/2023

Biological Therapies Need Clinical Trials: Califf, Marks 01/26/2023

Include all Media in Drug Promotion Regs: Professors 01/26/2023

CDRH OK’d 19 Breakthrough Devices in 2022 01/26/2023

Dental Practices Defrauded FDA: Justice Dept. 01/26/2023

Torrent Inspection Classified as Official Action Indicated 01/26/2023

No Evidence of Contaminated Cough Syrup in U.S.: FDA 01/26/2023

Panel Backs Plan to Harmonize Covid Vaccine Composition 01/26/2023

Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions 01/25/2023

Final Guide on Compounding Ibuprofen Suspensions 01/25/2023

Cardiosave Intra-Aortic Balloon Pumps Recalled 01/25/2023

Improving Myelodysplastic Syndromes Trials 01/25/2023

FDA Lifts Hold on Inhibikase Parkinson’s Trial 01/25/2023

BsUFA Regulatory Research Roadmap 01/25/2023

FDA/Aetion Oncology RWD Research 01/25/2023

GenBioPro Sues to Overturn WV Abortion Pill Law 01/25/2023

Merck Ending Keytruda Phase 3 Prostate Cancer Trial 01/25/2023

Panel Votes to Approve Cidara’s Rezafungin 01/25/2023

‘7 Deadly Sins’ at FDA Presentations: Mikkael Sekeres 01/24/2023

Biogen’s Lou Gehrig’s NDA Heads to Panel Review 01/24/2023

AdvaMed Device Sterilization Reg Proposals for EPA 01/24/2023

Lobbying Killed VALID Act: ProPublica 01/24/2023

Many Advertised Drugs Have Low Therapeutic Value: Study 01/24/2023

‘Objectionable Conditions’ in Larkin Hospital IRB 01/24/2023

‘Corrective Recall’ Asked for Hemodialysis Units 01/24/2023

2022 FDA Advertising, Promotion Enforcement Reviewed 01/24/2023

FDA Backs Status Quo in Orphan Drug Exclusivity 01/23/2023

FDA Moving to Annual Covid Strain Selection Like Flu 01/23/2023

FDA Releases Cannabis Clinical Research Guidance 01/23/2023

DePuy Synthes Pays $10 Million to Settle Kickback Scheme 01/23/2023

Petition Urges FDA to Regulate LED-pulsing Devices 01/23/2023

Advertising Group Hits Novartis on Kisqali DTC Ad 01/23/2023

Guidance on Ibuprofen Compounding to Help Shortages: FDA 01/20/2023

FDA Memo Recommends Califf Order Makena’s Withdrawal 01/20/2023

Medtronic Recalls Extended to More HeartWare Batteries 01/20/2023

Panel to Discuss Opioid Postmarketing Requirement 01/20/2023

FDA Lifts Clinical Hold on Pompe Gene Therapy 01/20/2023

ICH Quality Risk Management Guide Adopted by FDA 01/20/2023

Mend Lax Clinical Trial Reporting: Pallone 01/19/2023

FDA Denies Fresenius Glycopyrrolate Petition 01/19/2023

Contrast Agent, Radioactive Drug, OTC Drug Status Clarified 01/19/2023

Conformity Assessment Program Information Collection 01/19/2023

Surmodics SurVeil PMA ‘Not Approvable’: FDA 01/19/2023

FDA Amends, Repeals Some Rad Health Regs 01/19/2023

FDA Seeks Injunction Against LGM Pharma 01/19/2023

11 Observations on Intas Pharmaceuticals FDA-483 01/19/2023

Realize Medical Virtual Reality Surgical Tool Cleared 01/19/2023

Fix the Evidence Generation System Now: Califf 01/19/2023

Stakeholder Suggestions for IHC Q5A Guidance 01/18/2023

FDA Denies Petition on Gabapentin Scheduling 01/18/2023

FDA Wants RWD User Fee Funding Comments 01/18/2023

Janssen Ending Mosaico HIV Vaccine Trial 01/18/2023

Deny Mifepristone Preliminary Injunction: FDA 01/18/2023

Moderna to Seek RSV Vaccine OK 01/18/2023

Improve HHS Oversight of Pathogen Research: GAO 01/18/2023

CDER Continuing QMM Program Development 01/18/2023

Improve FDA Management of IT Contracts: OIG 01/17/2023

BsUFA 3 Changes Described 01/17/2023

Woman Sentenced in Drug Trial False Statement Case 01/17/2023

Appeals Court Nixes Sandoz Generic Aubagio Suit 01/17/2023

Sterile Drug Issues at Optum Infusion 01/17/2023

FDA Expands CN Bio Collaboration 01/17/2023

Diagnostics, Dietary Supplement Reforms on FDA Legislative Agenda 01/17/2023

Guide Seeks Dose Optimization in Cancer Drug Development 01/17/2023

Coviden Recalls Mahurkar Dialysis Catheter 01/13/2023

Novo Nordisk’s Rebelsus Now OK for 1st Line Use 01/13/2023

AstraZeneca Discontinuing Lumoxiti for Hairy Cell Leukemia 01/13/2023

FDA/CDC Dismiss ‘Signal’ with Pfizer Bivalent Vaccine 01/13/2023

5 Observations in Alembic FDA Inspection 01/12/2023

Stop Trying to Prevent Covid in Healthy People: Offit 01/12/2023

Dosage and Administration Label Section Guidance 01/12/2023

‘Minor Updates’ to 2 Covid Test Guidances 01/12/2023

Oramed Shelves Diabetes Drug After Phase 3 Miss 01/12/2023

Swiss-FDA Mutual Recognition Agreement 01/12/2023

Implementing Cybersecurity Provision in Spending Bill 01/12/2023

NCVHS Should Add UDIs to Claims Forms: Article 01/12/2023

Physicians Seek Panel Review for ‘Full Approval’ of Alzheimer’s Drug 01/12/2023

2 Olympus Endoscope Warning Letters 01/11/2023

PhRMA Expresses ICH Q12 Guidance Concerns 01/11/2023

Vaccine Advisors Angry at Lack of Transparency 01/11/2023

We Agree: FDA Should Jettison Foods 01/11/2023

Criminal Probe Nets 2 Guilty Pleas Over Stolen Test Strips 01/11/2023

Many Recalled 510(k) Devices Had Recalled Predicates: Study 01/11/2023

Attorneys Look Back, Ahead at FDA 01/11/2023

CGMP Violations at India’s Sun Pharmaceutical 01/10/2023

Standardizing REMS Information in SPL 01/10/2023

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