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Guide on Mycobacterial Pulmonary Disease 09/01/2023

Generic Post-Warning Letter Meetings Guide 09/01/2023

More Variants Cleared for 23andMe Genetic Test 09/01/2023

Universal Meditech Recalls All Test Products 09/01/2023

Hugel Refiles BLA Addressing FDA Concerns 09/01/2023

Sage Reorganizing to Support Zurzuave Launch 08/31/2023

BD Suggestions for Microbiology Panel 08/31/2023

Guide on Real-World Data/Evidence 08/31/2023

AdvaMed on At-Home Medical Technology Use 08/31/2023

Fight Bone Graft Infections: Michigan Lawmakers 08/31/2023

Keep FDA Logo Out of Materials: Agency 08/31/2023

FDA Quality Management White Paper 08/31/2023

Opioid Crisis Worse Despite Progress: Califf 08/31/2023

Real-World Evidence Regulatory Guidance 08/30/2023

FibroGen Duchenne Study Misses Endpoint 08/30/2023

Hamilton Medical Recalls Ventilators 08/30/2023

Drug Distribution Security Guidance 08/30/2023

Drug Tracing ‘Stabilization Period’ 08/30/2023

Comments on Increasing Home Medical Tech Use 08/30/2023

FDA Renews 5-Year M-CERSI Agreement 08/30/2023

Breakthrough Designation for Quest Diagnostic 08/30/2023

RAISE Program Explained 08/30/2023

CGMP Violations at K.C. Pharmaceuticals 08/29/2023

Gadal Laboratories CGMP Violations 08/29/2023

Tesla BioHealing Illegally Marketing Devices 08/29/2023

FDA Monitoring Social Media Drug Promotion: Post 08/29/2023

9 GA Congress Members Want Chemo Transparency 08/29/2023

FDA Promotes Dose Optimization Innovation: Report 08/29/2023

Texas Approves Drug Import Plan 08/29/2023

Lawmakers Ask FDA to Fix Orange Book Loopholes 08/29/2023

ICU Medical Infusion Pump Cleared 08/29/2023

Janssen Files sBLA for Expanded Rybrevant 08/28/2023

Data Integrity Issues at Synapse Labs: Petition 08/28/2023

FDA Clears BioProtect Balloon Implant 08/28/2023

AbbVie sBLA for Skyrizi in Crohn’s 08/28/2023

Novocure Phase 3 Study Misses Primary Endpoint 08/28/2023

Merck, Eisai Stop LEAP-010 Trial 08/25/2023

Enforcement Deferred on Drug Security Needs 08/25/2023

Comments Sought on Pepaxto’s Proposed Withdrawal 08/25/2023

CDRH Qualifies Tool on Material Biostability 08/25/2023

FDA OKs New Veklury Covid Indication 08/24/2023

Akebia Plans 3rd Quarter Vadadustat NDA Resubmission 08/24/2023

Fast Track for Abdominal Aneurysm Product 08/24/2023

Paragonix Donor Lung Preservation Device Cleared 08/24/2023

More Drug Approval Transparency Needed: Studies 08/24/2023

FDA Approves 1st Tysabri Biosimilar 08/24/2023

Finalized Informed Consent Guidance Analyzed 08/24/2023

FDA Panel to Review Diabetes NDA Dispute 08/23/2023

Regulate Cannabis Under Existing Law: CFCR 08/23/2023

Dingell Concerned About TB from Bone Grafts 08/23/2023

Changes Sought in FDA Diabetes Endpoint Guidance 08/23/2023

Lilly’s Retevmo Hits Phase 3 Trial PFS Endpoint 08/23/2023

‘Objectionable Conditions’ in Clinical Investigation 08/23/2023

OTC Devices ‘Don’t Need Patient Self-Diagnosis’: CHPA 08/22/2023

FDA Warns Walmart, Amazon on Molluscum Drugs 08/22/2023

Ambu Illegally Selling Airway Device: FDA 08/22/2023

Clinical Hold Lifted on Sickle Cell Drug 08/22/2023

Require Generic Ozobax Safety Data: Metacel 08/22/2023

FDA Reorg Could Hurt Supplements: Duncan 08/22/2023

Drug Shortages are National Security Risk: Califf 08/22/2023

OPDP Cites Exeltis’ Promos on Social Media 08/21/2023

Device Cybersecurity Guide Coming by 9/30: FDA 08/21/2023

Eylea OK’d After Fixing Inspection Findings 08/21/2023

FDA Partial Hold on Gilead’s Magrolimab 08/21/2023

NDA for Myelodysplastic Syndromes Anemia 08/21/2023

Drug Firms’ $300 Million Fine Over Price-Fixing 08/21/2023

Califf to Put Pressure on Indian Drug Makers 08/18/2023

Anika Gains Rotator Cuff Implant Clearance 08/18/2023

Veopoz OK’d and Eylea Issues Fixed: Regeneron 08/18/2023

Merck Touts Welireg in Kidney Cancer 08/18/2023

FDA Oks Ipsen’s Sohonos for FOP 08/17/2023

Cardiosave Balloon Pump Recall Class 1: FDA 08/17/2023

BlueWind De Novo for Incontinence Device 08/17/2023

Vanda Pushes Back on Hetlioz sNDA Hearing Denial 08/17/2023

Medical Device, Drug Recalls Drop in Q2: Sedgwick 08/17/2023

Orphan Status for Biliary Tract Cancer Drug 08/17/2023

Priority Review for Servier’s Tibsovo sNDA 08/16/2023

Abortion Drug Can Remain on Market: Appeals Court 08/16/2023

FDA’s Lighter Enforcement May be Ending: Attorney 08/16/2023

New FDA PathologAI Initiative 08/16/2023

Deficiencies in CM and RTRT-D NDA Submissions 08/16/2023

Multiple Denison Pharmaceuticals Violations 08/16/2023

CDRH Prefers Guidance Comments in Table Format 08/16/2023

AstraZeneca Gets 1st OPDP 2023 Warning Letter 08/15/2023

Informed Consent Guidance 08/15/2023

QS Violations at TEI Biosciences 08/15/2023

Hold Lifted on Arcellx Myeloma Drug 08/15/2023

Info Collection Revision on BLA Procedures 08/15/2023

FDA Denies St. Jude Codeine Use Petition 08/15/2023

More Supplements Risk Oversight Coming: Califf 08/15/2023

Breakthrough Status for AngioVac System 08/15/2023

Florida Amends FOIA Lawsuit Against FDA 08/14/2023

Clinical Hold on AML Cell Therapy 08/14/2023

FDA Extends Review of Chikungunya Vaccine 08/14/2023

Phillips Recalls Trilogy EVO Ventilators 08/14/2023

Biocon Malaysia Plant Hit with 8-item 483 08/14/2023

Guide on Off-the-Shelf Software in Devices 08/11/2023

Astellas sNDA Filed for Pediatric Cresemba 08/11/2023

Ceribell’s ClarityPro For Detecting Seizures 08/11/2023

FDA Warning on 15 Universal Meditech Tests 08/11/2023

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