Food and Drug Law Administrative Primer: Food and Drug Law Book 2 of 12

Food and Drug Law Administrative Primer: Food and Drug Law Book 2 of 12

by Roseann B. Termini, Esq.
Food and Drug Law Administrative Primer: Food and Drug Law Book 2 of 12

Food and Drug Law Administrative Primer: Food and Drug Law Book 2 of 12

by Roseann B. Termini, Esq.

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Overview

The focus of Book II is federal administrative law and agencies, particularly the United States Food and Drug Administration (FDA) and United States Department of Agriculture (USDA). The role of FDA is discussed and analyzed from an administrative law stance. The importance of understanding the impact of the administrative process concerning federal agencies cannot be overstated. Recognized as due process requirements under the Administrative Procedures Act (APA), agencies such as FDA and USDA must adhere to exact legal procedures in publishing proposed rules. These agencies must follow all the requirements under the APA, since they are both administrative agencies. The creation and powers of administrative agencies are included along with the administrative process.
What is the Federal Register? Think of the Federal Register as the daily newspaper of the Federal government. It is a legal newspaper and published every single business day by the National Archives and Records Administration (NARA). The Federal Register serves the official daily publication for rules, proposed rules, and notices of federal agencies that includes FDA and USDA.
What is the Code of Federal Regulations or CFR? The CFR is a compilation of the general and permanent rules published in the Federal Register by agencies of the federal government such as FDA and USDA. The regulations are organized by subject area and assigned a Title number. For example, Title 21 CFR concerns Food and Drugs. Every title is divided into chapters and each chapter is further subdivided into parts that cover specific regulatory areas. Practical food and drug law related examples from the Federal Register and the CFR are listed. Both the Federal Register and the CFR are important in the practice of food and drug law.
Book II contains an administrative law backgrounder that details the nuts and bolts of administrative law. The Food and Drug Administration simultaneously acts as a regulator of federal law, a watchdog and facilitator. Finally, this resource imparts a comprehensive review of key administrative law topics. Other administrative law topics include comment submission, the increased use of guidance documents and key agencies in food and drug law regulation. Each chapter contains critical analysis issues to explore. Suffice it to state, the APA preserves the requisites of due process.


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Product Details

BN ID: 2940160968292
Publisher: Forti Publications
Publication date: 01/07/2022
Series: Food and Drug Law , #2
Sold by: Barnes & Noble
Format: eBook
File size: 113 KB

About the Author

Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. These 12 volumes, each as a new eighth edition, emanate from her comprehensive sixth edition food and drug regulatory law book, “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products Regulation,” available at www.fortipublications.com. Ms. Termini presents and publishes in a broad array of specialized food and drug law topics, such as corporate accountability, enforcement, claims, supplements, safety, duty to warn, preemption, regulation, promotion, tobacco, stem cells, risk assessment, and globalization. She was the first recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, position as sole corporate counsel, regulatory attorney, and senior deputy attorney general at the Pennsylvania Office of Attorney General. Ms. Termini designed and developed the inaugural online food and drug law courses at Widener University School of Law, Johns Hopkins University, the University of Georgia, Drexel University, and a direct to consumer promotion course at St. Joseph’s University’s Executive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulatory Affairs Graduate Program and Penn State-Dickinson School of Law. Ms. Termini has been active on the committees of several professional associations for many years, including her service as Chair of a Food and Drug Law Institute Committee. She has also served on the President’s Council, at Immaculata University and is a member of the Central Atlantic Association of Food and Drug Law Officials. Ms. Termini was admitted in 2018 to the bar of the United States Supreme Court.

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