Lecture 4_2011

Lecture 4_2011 - Successfully Navigating the FDA Regulatory...

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Unformatted text preview: Successfully Navigating the FDA Regulatory Environment Janice M. Hogan, Partner Hogan Lovells US LLP www.hoganlovells.com 2 FDA Responsibilities All human drugs Vaccines Medical devices Tissues for transplantation Equipment that emits radiation Cosmetics Animal drugs Most foods Almost 25% of all US consumer spending (> $1.5 trillion/year) is on FDA regulated products safety efficacy www.hoganlovells.com 3 Overview What is the FDAs mission? What are the timelines and costs for approval? What is the best strategy for interacting with the FDA (who, when, how, and how often)? www.hoganlovells.com 4 FDA Mission Statement The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, to provide the public accurate, science-based information needed regarding medicines and foods to improve their health. www.hoganlovells.com 5 Food and Drug Administration Commissioner of Food and Drugs Thin layer of political appointees compared to other government agencies; large career component/PHS www.hoganlovells.com 6 FDA Structure and Responsibilities CDRH - Review and Approval/Clearance of Medical Devices ( e.g ., processed human dura matter, adhesion barriers, surgical meshes containing human or animal-derived materials) CDER - Review and Approval of Prescription, Over- the-Counter, and Generic Drugs CBER - Review and Approval of Biologics, Donor Screening and Blood Establishment Products www.hoganlovells.com 7 FDA Employees ~10,000 employees (~6000 in Washington) Headquarters: focus on product review and regulatory policy Field offices all around the country: inspections, labs, outreach/education Many but not all managerial positions filled by MDs or PhDs Physicians, chemists, engineers, biologists, physicists, veterinarians, toxicologists, microbiologists, statisticians, epidemiologists, regulatory project managers, public health education spets, and many others Commissioned PHS is a significant part of FDAs work force Because of breadth of scientific disciplines FDA must cover, the Agency may not always have in house expertise on every field of medicine in each center www.hoganlovells.com 8 Food, Drug and Cosmetic Act 1938: Manufacturers required to provide FDA with evidence of the safety of new drug BEFORE marketing Impetus: Elixir of Sulfanilamide containing same chemical as antifreeze New Drug Application (NDA) required to show safety FDA could only disapprove an NDA Added injunction authority Authorized factory inspections 1962: Efficacy amendments: Manufacturers required to provide FDA with evidence of safety and effectiveness of new drug BEFORE marketing Impetus: thalidomide www.hoganlovells.comwww....
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This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

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Lecture 4_2011 - Successfully Navigating the FDA Regulatory...

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