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FDA, Rocket Agree on Phase 2 Danon Disease Trial 09/13/2023

Safety Concerns Stop Eiger Phase 3 Hepatitis Trial 09/13/2023

Supremes May Hear Label Preemption Case: Attorneys 09/13/2023

Include ICH Q12 in Gene Therapy Guidance: ISPE 09/13/2023

White House Credits FDA on Drug Shortages 09/13/2023

Abbott Recalls Proclaim Pulse Generators 09/13/2023

‘Good Cause’ Guidance Needs Flexibility: PhRMA 09/13/2023

Bipartisan Legislation on Patent Listings 09/13/2023

FDA Questions Efficacy of Patisiran sNDA 09/12/2023

FY 2022 GDUFA Science, Research Outcomes 09/12/2023

Safecor Health CGMP Violations 09/12/2023

Similasan Marketing Unapproved New Drugs: FDA 09/12/2023

FDA Warns 8 Firms for Unapproved Eye Drugs 09/12/2023

CDER Defends Pepaxto Withdrawal Proposal 09/12/2023

2 FDA Recommendations in Patient Safety Report 09/12/2023

White Paper on Preventing Drug Shortages 09/12/2023

Panel Votes Down OTC Cold Ingredient 09/12/2023

Mallinckrodt Recalls One-Way Ventilator Valve 09/12/2023

Jury Convicts 2 for Clinical Trial Fraud 09/12/2023

FDA Permanently Debarring Tatsene 09/12/2023

45 Device Alerts Issued in 2022: FDA 09/11/2023

Justice Petitions Supreme Court Over Mifeprex 09/11/2023

Updated Covid-19 Vaccines Approved by FDA 09/11/2023

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

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