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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

New AI Transparency Minimums Needed: Column 01/10/2023

FDA, Health Canada Open eSTAR Pilot 01/10/2023

AdvaMed Recommendations on Consensus Standards 01/10/2023

NDA/BLA Approval Metrics Take a Hit in 2022 01/10/2023

CDER Dismisses 26% Drop in 2022 Drug Approvals 01/09/2023

BioMarin Filing Additional Data for Hemophilia Gene Therapy 01/09/2023

Troubled Zyno Pays $493K over False Claims 01/09/2023

Review extension for Krystal Gene Therapy BLA 01/09/2023

CardiacSense Vital Signs Watch Cleared by FDA 01/09/2023

Law Extends Product Info Sharing Safe Harbor to Devices 01/06/2023

Evusheld May Not Neutralize New Covid Variant: FDA 01/06/2023

FDA Hits Ipsen with Complete Response on Palovarotene 01/06/2023

Generic Drug Controlled Correspondence Revised Guidance 01/06/2023

ODT Launches Leadership Modernization Action Plan 01/06/2023

FDA Delays Toripalimab PDUFA Action Date 01/06/2023

Cavazzoni Tries to Repair Credibility with New Alzheimer’s OK 01/06/2023

Lupin Recalls 4 Quinapril Lots 01/05/2023

FDA Approves Zycosan for Horses with Osteoarthritis 01/05/2023

Reverse ‘Calif. Consumer Protection Regime’: WLF 01/05/2023

Genentech’s Lunsumio OK’d for Some Lymphomas 01/05/2023

REMS Document Technical Conformance Guide 01/05/2023

Jet Medical, Other Companies, Pay $700,000 in Device Cases 01/05/2023

Checkpoint Therapeutics BLA for Skin Cancer 01/05/2023

5 Observations on Glenmark FDA-483 01/05/2023

FDA Approves Rozlytrek Companion Diagnostic 01/05/2023

Group Urges Postponement of Alzheimer’s Drug Decision 01/05/2023

Build Flexibility into Pubertal Development Guidance: BIO 01/05/2023

AstraZeneca BLA for RSV Prevention in Infants 01/05/2023

Medical Device Consensus Standards Database Updated 01/04/2023

FDA Changes Mifepristone REMS 01/04/2023

FDA Reforms Included in Year-end Omnibus Bill 01/04/2023

Accord Healthcare Recalls 2 Daptomycin Products 01/04/2023

FDA Approves Acer’s Olpruva for Urea Cycle Disorders 01/04/2023

RoyalVibe Health Refused Inspection: FDA 01/04/2023

Inspection Issues at Sagent’s Plattsburgh Facility 01/04/2023

FTC Updates Health Products Compliance Guide 01/04/2023

CGMP Deviations Found at MD Pharmaceutical Supply 01/04/2023

FDA Delays PDUFA Action Date for Phathom’s Vonoprazan 01/04/2023

New Alzheimer’s Drug OK This Week Won’t Do Much for Patients: Article 01/04/2023

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