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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

Danco Seeks High Court Abortion Drug Review 09/08/2023

ISO 10993-1 Clarifying Guidance 09/07/2023

No Marketing of Same Rx and OTC Drugs: Reps 09/07/2023

Philips $615 Million Settlement Over Faulty Devices 09/07/2023

Janssen Stops Macitentan Phase 3 Study 09/07/2023

FDA Update on Bone Matrix TB Issue 09/07/2023

Human Factors Engineering Q&A Guidance 09/07/2023

Suggestions for ICH Good Clinical Practice Guideline 09/07/2023

3 New 510(k) Guidances 09/06/2023

Positron Emission Tomography Meeting Set 09/06/2023

Rybrevant Hits Phase 3 Goals in Some Lung Cancers 09/06/2023

FDA Denies ICAN Pertussis Labeling Petition 09/06/2023

‘Strong Response’ in New Moderna Covid Vaccine 09/06/2023

FDA, Flatiron Health Real-world Data Pact 09/06/2023

Breakthrough Status on Auto Glucose Device 09/06/2023

Appeals Court Reverses Ivermectin Suit Dismissal 09/05/2023

Techsomed Ablation Planning Software Cleared 09/05/2023

CGMP Violations at Lex, Inc. 09/05/2023

Mycobacterial Pulmonary Disease Draft Guide 09/05/2023

Generic Drug Warning Letter Meetings Guide 09/05/2023

Meeting on Reauthorizing OTC Drug User Fees 09/05/2023

Green Pharma Warned Over CGMP Issues 09/05/2023

Interoperable Info Exchange Guidance 09/05/2023

Robot Authorized to Disinfect Medical Surfaces 09/05/2023

‘Urgent Action’ on Puberty Blockers Sought 09/05/2023

FDA Informed Consent Final Guidance 09/05/2023

Primary Endpoint Met in Alecensa Study: Roche 09/01/2023

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

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