The Food and Drug Administration Safety and Innovation Act

The Food and Drug Administration Safety and Innovation Act PDF

Author: James C. Perry

Publisher: Nova Science Publishers

Published: 2014-02

Total Pages: 0

ISBN-13: 9781629487748

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The Food and Drug Administration Safety and Innovation Act (FDASIA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities. Frequently referred to as the user fee reauthorisation act, FDASIA does include four titles relating to user fees. This book focuses on these acts, as well as the prescription drug user fee act, the FDA medical device user fee program and discusses the proposed FDA user fee acts generic drug user fee amendments.

The Food and Drug Administration Safety and Innovation Act (P.L. 112-144).

The Food and Drug Administration Safety and Innovation Act (P.L. 112-144). PDF

Author: Susan Thaul

Publisher:

Published: 2012

Total Pages:

ISBN-13:

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This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.

FDA Regulatory Affairs

FDA Regulatory Affairs PDF

Author: David Mantus

Publisher: CRC Press

Published: 2014-02-28

Total Pages: 402

ISBN-13: 1040079180

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FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Crs Report for Congress

Crs Report for Congress PDF

Author: Susan Thaul

Publisher: BiblioGov

Published: 2013-11-11

Total Pages: 26

ISBN-13: 9781295273966

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UPDATE: S. 3187, the Food and Drug Administration Safety and Innovation Act, scheduled for floor consideration, is an amended version of S. 2516, reported by the Senate Committee on Health, Education, Labor, and Pensions. The House Committee on Energy and Commerce voted favorably to report H.R. 5651, the Food and Drug Administration Reform Act of 2012. Both the Senate and House bills include titles to reauthorize FDA prescription drug and medical device user fee programs, authorize new user fee programs for generic drugs and biosimilar biological products, and amend the Federal Food, Drug, and Cosmetic Act regarding the regulation of drugs and medical devices. (Note: The rest of this report has not been updated since September 1, 2011.) The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers' applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDA's responsibilities regarding drug approval and regulation.

Mastering and Managing the FDA Maze, Second Edition

Mastering and Managing the FDA Maze, Second Edition PDF

Author: Gordon Harnack

Publisher: Quality Press

Published: 2014-04-14

Total Pages: 488

ISBN-13: 0873898877

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The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions

Permanent Discontinuance Or Interruption in Manufacturing of Certain Drug Or Biological Products (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

Permanent Discontinuance Or Interruption in Manufacturing of Certain Drug Or Biological Products (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) PDF

Author: The Law The Law Library

Publisher: Createspace Independent Publishing Platform

Published: 2018-09-22

Total Pages: 58

ISBN-13: 9781727540314

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Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products-including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application-to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States. This book contains: - The complete text of the Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

Antimicrobial Drug Resistance

Antimicrobial Drug Resistance PDF

Author: Douglas Mayers

Publisher: Springer Science & Business Media

Published: 2009-07-14

Total Pages: 692

ISBN-13: 1603275959

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This ? rst edition of Antimicrobial Drug Resistance grew out of a desire by the editors and authors to have a comprehensive resource of information on antimicrobial drug resistance that encompassed the current information available for bacteria, fungi, protozoa and viruses. We believe that this information will be of value to clinicians, epidemiologists, microbiologists, virologists, parasitologists, public health authorities, medical students and fellows in training. We have endeavored to provide this information in a style which would be accessible to the broad community of persons who are concerned with the impact of drug resistance in our cl- ics and across the broader global communities. Antimicrobial Drug Resistance is divided into Volume 1 which has sections covering a general overview of drug resistance and mechanisms of drug resistance ? rst for classes of drugs and then by individual microbial agents including bacteria, fungi, protozoa and viruses. Volume 2 addresses clinical, epidemiologic and public health aspects of drug resistance along with an overview of the conduct and interpretation of speci? c drug resistance assays. Together, these two volumes offer a comprehensive source of information on drug resistance issues by the experts in each topic.

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