Feldschreiber's comprehensive text on the science, regulatory policy and law surrounding new medicines and medical devices is a specialist reference for legal, medical, and pharmaceutical professionals. Written by both legal and medical experts, it informs the scientifically lay lawyer of the biological science behind recent product innovations, whilst helping the legally lay researcher and developer of these products to understand the legal and regulatory framework encompassing them.
Reflecting significant legal and scientific advancements since its first publication in 2008, this second edition, now entitled The Law and Regulation of Medicines and Medical Devices, has been substantially revised and reframed: key areas of review include medical device regulatory legislation (including the new Medical Devices Regulation), international regulatory procedures for life science products, the UK review on blood products, new cancer therapies, the impact of Brexit and the Covid-19 pandemic, and a greatly expanded discussion of criminal legislation on the cultivation of controlled drugs, such as cannabis, and their inclusion in the medical therapeutic armamentarium.
The work introduces the structure and function of regulatory authorities and the linkage between the ethical issues underpinning clinical trials regulation, explains the intellectual property, product liability, and litigation issues surrounding life science products, and offers practical guidance on topics such as: drafting regulatory submissions; preparing litigation against decisions of the regulatory authorities; determining appropriate regulatory submission strategies throughout the European Community; and preparing litigation relating to medicinal products liability under the Product Liability Directive and the Consumer Protection Act 1987
New to this edition:
- Comprehensive discussion of the medical device regulatory legislation, including the new Medical Devices Regulation and other major legislative changes
- New and expanded sections on product liability, immunology, molecular biology and monoclonal antibodies, oncology and haematology, tissue engineering, stem cells, gene editing, and personalized medicine
- Considers the impact of Brexit and the Covid-19 pandemic on the regulatory and overall legal frameworks for medicines and medical devices
- Expanded discussion of criminal legislation addressing the cultivation of controlled drugs