Access to investigational
treatments requires the active cooperation of the FDA, industry, and health care professionals in order to be successful.
This new approach will begin as a pilot program focused on a single Janssen investigational
medicine and, if successful, will become a model that will be applicable more broadly across J&J, says the company.
Global healthcare company Merck (NYSE;MRK) announced on Monday the signing of a non-exclusive agreement with Bristol-Myers Squibb (NYSE:BMY) to conduct a Phase II clinical trial to evaluate the safety and efficacy of a once-daily oral combination regimen consisting of Bristol-Myers Squibb's investigational
NS5A replication complex inhibitor daclatasvir and Merck's investigational
NS3/4A protease inhibitor MK-5172 for the treatment of chronic hepatitis C virus (HCV) infection, genotype 1.
These two rules clarify and improve FDA practices on investigational
drugs, how they can be used prior to approval," Dr.
The FDA has provided access to investigational
agents in the past, but the new rules are intended to clarify and offer these options to more patients, Dr.
The FDA states that it has taken this action to focus a manufacturer ' s effort on applying GMP that is appropriate and meaningful for the manufacture of the earliest stage investigational
drug products intended for use in Phase 1 clinical trials while ensuring safety and quality.
The company reports it sponsored an open label investigational
clinical trial in Moscow, Russia last year at the Central Clinical Research Institute of Eyes, which successfully halted corneal transplant rejection in all 13 patients by using the investigational
antibodies as a topical treatment in the form of eye drops.
is a development-stage pharmaceutical company based in San Diego, California, working to become the world leader in the development of a new class of investigational
drugs known as Immune Regulating Hormones (IRHs).
The reason for this is simple: a phase 1 study marks the first time humans receive an investigational
drug and researchers want to minimize harm if the therapy proves unsafe.
Your policy states that this technology would be considered investigational
, due to lack of long-term data on whether detection and management of this risk factor will lead to improved health outcomes.
Clinical research often will compare an investigational
treatment to one that is used frequently and thus has familiar, or predictable, effects.
Food and Drug Administration (FDA) regarding certain statements made about the Company's investigational
therapy Multikine (Leukocyte Interleukin, Injection)* on its corporate website.
WASHINGTON -- The Food and Drug Administration has published two rules to clarify the methods available to seriously ill patients interested in gaining access to investigational
drugs and biologics when they are not ineligible for a clinical trial and lack other satisfactory treatment options.
On 14th December, 2006 the US Federal Food and Drug Administration (FDA) issued proposed regulations intended to make investigational
new drugs more widely available to seriously ill patients with no other treatment options, and to clarify the circumstances and costs for which drug manufacturers may charge for experimental drugs.
They point out that it is arbitrary to separate investigational
elements of a treatment from issues of basic patient care.