FDA Notifications
Prism HIV O Plus assay licensed
The Food and Drug Administration (FDA) licensed, on Sept. 18, 2009, the Abbott Prism HIV O Plus assay, a new screening tool designed to detect the presence of antibodies to the two types of the virus that causes AIDS, HIV 1 and HIV 2. Both types can be transmitted by sexual contact, through blood, and by mother to child transmission.
The new assay is one of five assays that run on the fully automated Abbott Prism System.
HIV type 1 consists of various subgroups, including group M, the most common subgroup of the virus in the United States, and group O, found primarily in Cameroon and other areas of West Africa.
HIV type 2 is found mostly in West Africa. Both types have been detected in the United States and Europe.
The Abbott Prism HIV O Plus assay detects antibodies to HIV type 1, groups M and O, and HIV type 2. It is the second donor screening test licensed for the detection of antibodies to HIV type 1, group O.
The Abbott Prism HIV O Plus assay is licensed to screen donated blood and blood specimens from other living donors (e.g., organ or tissue donors) for these specific types of HIV and subgroups of HIV type 1. The assay is also licensed to screen specimens from organ donors when specimens are obtained while the donor's heart is still beating and from cadavers. Positive results from the screening test require confirmation from supplemental tests.
The Abbott Prism HIV O Plus assay and the Abbot Prism system are manufactured by Abbott Laboratories, Abbott Park, Ill.
FDA approves generic combination of efavirenz, lamivudine & tenofovir
On Sept. 3, 2009, the FDA granted tentative approval for a generic fixed-does combination tablet containing efavirenz, lamivudine, and tenofovir disoproxil fumarate, 600mg/300mg/300mg. This new fixed-dose combination is manufactured by Matrix Laboratories Limited of Hyberdad, India. It is indicated for use alone or in combination with other antiretroviral products for the treatment of HIV-1 infection.
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval or marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR).
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found on the FDA web site.
FDA published 2 new rules regarding INDs
On Aug. 12, 2009, the Food and Drug Administration (FDA) published two new rules related to investigational drugs.
One new rule, "Expanded Access to Investigational Drugs for Treatment Use," seeks to clarify the methods available to seriously ill patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need to safeguard the individual patient and ensure the continued integrity of the scientific process that brings safe and effective drugs to the market. The second, "Charging for Investigational Drugs Under an Investigational New Drug Application," clarifies the specific circumstances and the types of costs for which a manufacturer can charge a patient for an investigational drug, either as part of a clinical trial, or for treatment use outside the scope of a clinical trial through expanded access.
The changes are meant to consolidate and clarify the requirements and facilitate making investigational drugs and biologics more widely available to seriously ill patients, including those with HIV/AIDS, who have no other treatment options. The proposed changes also seek to clarify the specific circumstances and the types of costs for which a manufacturer can charge for an investigational drug made available for the purpose of treatment, or in clinical trials.
The FDA hopes the new rules will increase awareness in the patient and healthcare communities of the range of options available for obtaining investigational drugs for seriously ill patients, encourage companies to make such drugs available, and reduce barriers to obtaining them.
The new expanded access rule defines three categories of patient populations to whom investigational drugs could be made available for the purpose of treatment outside of a clinical trial through expanded access, when there is no satisfactory alternative therapy, and defines requirements and safeguards for each. They are individual patients, groups of patients smaller than that typical of a treatment IND or treatment protocol (FDA may ask a sponsor to consolidate expanded access under this section when the agency has received a significant number of requests for individual patient expanded access to an investigational drug for the same use), and larger populations where widespread treatment use is appropriate (the Treatment IND).
The FDA has allowed many types of access to investigational therapies since the 1970s. Some of the larger programs, including those under the Treatment IND (Investigational New Drug) regulations, enabled tens of thousands of patients with HIV/AIDS, cancer and cardiovascular diseases to receive promising therapies before the products were approved for marketing. However, the existing regulations did not adequately describe the full range of programs available, explicitly recognizing only emergency use for individual patients, and widespread treatment use access for large groups of patients. The new rule is meant to clearly reflect the full range of treatment use programs available, and ensure broad and equitable access to investigational drugs for treatment use.
The new rule updates applicable regulations to include all circumstances under which access to investigational drugs is permitted.
The Food and Drug Administration (FDA) licensed, on Sept. 18, 2009, the Abbott Prism HIV O Plus assay, a new screening tool designed to detect the presence of antibodies to the two types of the virus that causes AIDS, HIV 1 and HIV 2.Subscribe Now for Access
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