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Latest posts
Last updated about 18 hours ago
FDA/MHRA/Health Canada Symposium: Regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice - 06/02/2026
about 18 hours ago
This symposium will highlight current and emerging topics of interest to the...
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
about 18 hours ago
This guidance is the third in a series of four methodological patient-focused...
Natural Disaster Preparedness and Response | Drugs
about 19 hours ago
Stay informed on FDA's guidance for drugs used in natural disaster preparedness...
Genetic Metabolic Diseases Advisory Committee (GeMDAC) Charter
4 days ago
The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food...
Real-World Evidence
4 days ago
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in...
List of Drug Master Files (DMFs)
5 days ago
The list is updated quarterly. Changes are made to the DMF activity...
Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations
5 days ago
Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for...
Products Claiming to "Cure" Cancer Are a Cruel Deception
5 days ago
Many ads on social media and "healthy" websites claim their products can...
Bodynplant - Online Advisory Letter
5 days ago
FDA Online advisory letter issued to Bodynplant/bodynplant.com for serious disease claims, including...
Clinical Outcome Assessment (COA): Frequently Asked Questions
5 days ago
Clinical Outcome Assessments (COA) Frequently Asked Questions