Community resources and publications

FDA guidance on development trials for multidrug resistant HIV

On 16 December 2010 the FDA published new draft guidance for industry entitled “Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.” This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition.

This guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. It is open now for public comment, requested by 14 February 2011.

Recent scientific advances have increased our understanding of the pathophysiological processes that underlie many complex diseases, such as cancer, cardiovascular disease, and infectious diseases, including HIV. This increased understanding has provided further impetus for new therapeutic approaches that rely primarily or exclusively on combinations of drugs directed at multiple therapeutic targets to improve treatment response and minimise development of resistance.

In settings in which combination therapy provides significant therapeutic advantages, there is growing interest in the development of combinations of investigational drugs not previously developed for any purpose. Because the existing developmental and regulatory paradigm focuses primarily on assessment of the effectiveness and safety of a single new investigational drug acting alone, or in combination with an approved drug, FDA believes guidance is needed to assist sponsors in the codevelopment of two or more unmarketed drugs.

This guidance is intended to describe a highlevel, generally applicable approach to codevelopment of two or more unmarketed drugs. It describes the criteria for determining when codevelopment is an appropriate option, makes recommendations about nonclinical and clinical development strategies, and addresses certain regulatory process issues.

The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs, nor to vaccines, gene or cellular therapies, blood products, or medical devices.

Diseased Pariah News – archive online

This influential community publication has now been archived online.

This magazine was produced before HAART was available, and written by activists who were unable to benefit from treatment when it did arrive.

But the style, anger and humour (“Hostess with the Toxoplasmostest”, the “Get Fat, Don’t’ Die” recipe column, “Ask Aunt Kaposi”, centrefold pin-ups with the models CD4 count and current meds, etc) used by these activists to challenge complacency still stands head and shoulders above most of worthy publications that followed.

This is uncomfortable reading from a historical perspective. Know your history.

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