In its all-new edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:. Reader Testimonials: "This book provides the most comprehensive and up-to-date analysis of FDA's new drug development process available today. I recommend this well-written book for professionals engaged in the drug development and review process.
How It Works. How to fill out and sign eCTD online? Open it with cloud-based editor and start adjusting. Fill in the blank fields; involved parties names, addresses and phone numbers etc. Customize the blanks with smart fillable fields. Include the date and place your electronic signature. Click Done after twice-checking all the data. Download the ready-created record to your gadget or print it out as a hard copy.
Condition: New. Brand New!. Seller Inventory VIB Book Description Hard Cover. Mark Mathieu. Publisher: Parexel Intl Corp , This specific ISBN edition is currently not available. View all copies of this ISBN edition:. Barnett International Publication. Email a friend. Add to cart. In its all-new edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including: How the FDA Amendments Act of will affect everything from drug reviews to postmarketing requirements.
How the CDER's efforts to integrate a 'culture of drug safety' has affected the center's structure and its new drug review and approval processes.
0コメント