From test tube to patient : new drug development in the United States.

Mode of access: Internet.

US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins

Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfractionated heparin as antithrombotic therapy for patients with acute coronary syndromes. Each approved LMWH is a pleotropic biological agent with a unique chemical, biochemical, biophysical and biological profile and displays different pharmacodynamic and pharmacokinetic profiles. As a result, LMWHs are neither equipotent in preclinical assays nor equivalent in terms of their clinical efficacy and safety. Previously, the US Food and Drug Administration (FDA) cautioned against using various LMWHs interchangeably, however recently, the FDA approved generic versions of LMWH that have not been tested in large clinical trials. This paper highlights the bio-chemical and pharmacological differences between the LMWH preparations that may result in different clinical outcomes, and also reviews the implications and challenges physicians face when generic versions of the original/innovator agents are approved for clinical use.

Notices of judgment under the Food and drugs act.

Nos. 2986-15000, Aug. 3, 1914-June, 1927, issued as Supplements to Service and regulatory announcements of the Bureau of chemistry. Beginning with no. 3501, Apr. 3, 1915, Supplements are numbered consecutively S.R.A. Chem. suppl. 1-230.

The regulation of pesticides in the United States /

Cover title.

Parathion data presented to U.S. Food and Drug Administration, in the matter of: tolerances for poisonous or deleterious residues on or in fresh fruits and vegetables.

Cover-title.

FDA consumer nutrition knowledge survey : a nationwide study of food shopper's knowledge, beliefs, attitudes, and reported behavior regarding food and nutrition /

Includes bibliographical references.

Pesticide chemicals: regulations under the Federal food, drug, and cosmetic act.

Kept up-to-date by revised pages which are inserted.

Drugs--current good manufacturing practice in manufacture, processing, packing, or holding. : regulations under the Federal Food, Drug, and Cosmetic Act, Part 133, Title 21, Code of Federal Regulations. Part 191, Hazardous substances.

Mode of access: Internet.

Notices of judgement under the Federal food, drug, and cosmetic act ...

Mode of access: Internet.

Notices of Judgment under the Federal Food, Drug, and Cosmetic Act. Drugs and Devices

Mode of access: Internet.

Just label it: Consumer rights, GM food labelling, and international trade

In the United States, there has been fierce debate over state, federal and international efforts to engage in genetically modified food labelling (GM food labelling). A grassroots coalition of consumers, environmentalists, organic farmers, and the food movement has pushed for law reform in respect of GM food labelling. The Just Label It campaign has encouraged United States consumers to send comments to the United States Food and Drug Administration to label genetically modified foods. This Chapter explores the various justifications made in respect of genetically modified food labelling. There has been a considerable effort to portray the issue of GM food labelling as one of consumer rights as part of ‘the right to know’. There has been a significant battle amongst farmers over GM food labelling – with organic farmers and biotechnology companies, fighting for precedence. There has also been a significant discussion about the use of GM food labelling as a form of environmental legislation. The prescriptions in GM food labelling regulations may serve to promote eco-labelling, and deter greenwashing. There has been a significant debate over whether GM food labelling may serve to regulate corporations – particularly from the food, agriculture, and biotechnology industries. There are significant issues about the interaction between intellectual property laws – particularly in respect of trade mark law and consumer protection – and regulatory proposals focused upon biotechnology. There has been a lack of international harmonization in respect of GM food labelling. As such, there has been a major use of comparative arguments about regulator models in respect of food labelling. There has also been a discussion about international law, particularly with the emergence of sweeping regional trade proposals, such as the Trans-Pacific Partnership, and the Trans-Atlantic Trade and Investment Partnership. This Chapter considers the United States debates over genetically modified food labelling – at state, federal, and international levels. The battles often involved the use of citizen-initiated referenda. The policy conflicts have been policy-centric disputes – pitting organic farmers, consumers, and environmentalists against the food industry and biotechnology industry. Such battles have raised questions about consumer rights, public health, freedom of speech, and corporate rights. The disputes highlighted larger issues about lobbying, fund-raising, and political influence. The role of money in United States has been a prominent concern of Lawrence Lessig in his recent academic and policy work with the group, Rootstrikers. Part 1 considers the debate in California over Proposition 37. Part 2 explores other key state initiatives in respect of GM food labelling. Part 3 examines the Federal debate in the United States over GM food labelling. Part 4 explores whether regional trade agreements – such as the Trans-Pacific Partnership (TPP) and the Trans-Atlantic Trade and Investment Partnership (TTIP) – will impact upon

Food safety policy : scientific and societal considerations : part 2 of a two-part study of the Committee for a Study on Saccharin and Food Safety Policy.

Mode of access: Internet.