FDA Regulatory Science

This book is a primary guide to the prescription drugs, biologics, and biosimilars development and the corresponding regulatory affairs according to the FDA in the United States, covering the latest developments in regulations, electronic document submissions, and interaction with the regulatory authorities. This book covers generic drugs, drug development and approval in special populations and situations, while also providing current FDA regulatory stipulations. This is an ideal book for regulatory affairs professionals, drug developing companies, healthcare administrators, and students and researchers in clinical disciplines. Inhaltsverzeichnis Part I: Foundations of FDA Regulatory Science and the Digital Era.- Introduction to FDA Regulation: Science, Innovation, and the Digital Future.- International Regulatory Authorities, Digital Transformation & AI in Drug Development.- CMC: Risk Management, Structured Data, E-Submissions & AI/ML Integration.- Clinical Trials Multi-Stakeholder Ecosystem, Enforcement, DCT, AI/ML.- IND, NDA/BLA, Medical Devices, FDA-Sponsor Meetings, PDUFA Fees & AI/ML Integration.- Strategic Engagement: Navigating the Landscape of FDA/Sponsor Meetings.- Part II: Submissions, Approvals, and Drug Delivery.- Electronic Regulatory Submissions: ANDA Amendments, eCTD, ESG & AI/ML.- Generic Drug Approval: ANDA Pathway, Bioequivalence, Complex Generics & AI/ML.- The Biologics License Application: BLA, Biosimilars & AI/ML.- Lipid-Based Nano-Drug Delivery Systems for Lung Cancer.- Part III: Medical Devices, Combination Products, and Specialized Therapeutics.- Regulation of Medical Devices: Pathways, IDE, AI/ML & Post-Market Oversight.- Orphan Drug Development and the Evolving Regulatory Landscape.- FDA Inspection, Audit Process, and the Form 483: Challenges, Resolutions, and the AI Era.- Combination Products: Regulatory Frameworks, SaMD, and AI/ML in Medical Devices.- Drug Labeling: Regulatory Requirements, DTC Advertising, and the Role of AI.- Part IV: Emerging Therapeutics, Novel Technologies, and Post-Market Obligations.- Rare Diseases, CAR-T Cell Therapy, CRISPR, and Advanced Genetic Technologies.- Nanomaterials in Pharmaceutical Science: Technology, Regulatory Frameworks, and Artificial Intelligence.- Post-Marketing Surveillance and Pharmacovigilance Strategy: Drugs, Biologics, and Medical Devices.- Part V: Quality Systems, Global Regulation, and Public Health Preparedness.- Quality Management, Inspections, and Regulatory Compliance: Drugs and Medical Devices.- Global Regulatory Bodies: International Cooperation, Harmonization, and the Role of AI/ML.- Part VI: Medical Countermeasures, Digital Regulation, and the Future of FDA Science.- Medical Countermeasures to Protect Against Threats to U.S. and Global Health.- Software Platforms for Regulatory Affairs and Clinical Trial Management. Autorenportrait Shahid Siddiqui studied at the Tata Institute of Fundamental Research, Bombay and obtained Ph.D. in Molecular Biology and Genetics, working at the Max-Planck Institute for Experimental Medicine in Gottingen, Germany. He has been a faculty member at University of Chicago, the University of Illinois, Toyohashi University of Technology in Japan, and the U.Q. University in Saudi Arabia. Currently affiliated with the Niazee College of Osteopathic Medicine. He is Founder and President of the McGenome LLC, Illinois, USA where he provides consultancy services in Regulatory Affairs and Drug and Medical Device Development. He has also served among others the NEC Corporation, Sumitomo Inc. Japan, Abbott, and the Medline LP companies.