A workbook for day-to-day decisions Nutrition labels on various food products must comply with numerous, ever-changing requirements. Items such as meat and poultry products, food packages, and dietary supplements are subject to stringent federal regulations-and the costs of compliance are often significant. The Nutritional Labeling and Education Act of 1990 (NLEA) imposed new mandates for labeling of many packaged food products; still others became subject to a voluntary nutrition labeling program. Following that lead, USDA has imposed parallel labeling requirements. FDA and USDA Nutrition Labeling Guide: Decision Diagrams, Checklists, and Regulations provides hands-on information and guidelines for understanding the latest federal nutrition labeling requirements. This plain English analysis of FDA and FSIS labeling rules contains diagrams and tables and cites specific regulations. Decision diagrams walk the reader through volumes of information and make sense out of complicated regulatory processes. Checklists for managing information for developing specific labels help the reader track regulatory changes and document regulation applicability to company products. The RegFinder index references not only the text, but also provides hundreds of regulatory citations, referenced by topic. FDA and USDA Nutrition Labeling Guide: Decision Diagrams, Checklists, and Regulations will be of interest to food industry personnel responsible for compliance with federal nutritional labeling regulations, food product developers and food technologists. Faculty teaching food laws and regulations and food product development will also find this book of interest.

Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.