By Linda A. Johnson, AP Business Writer WASHINGTON — Generic drugs go through what the Food and Drug Administration calls an abbreviated approval process. But it takes three times as long as FDA reviews of new experimental drugs because of the sheer volume of applications, many of which are submitted years before the original drug’s […]
FDA Approved New DPT Vaccine for Seniors
By Christina England It has been announced that a new vaccine has been approved by the FDA for the over 65′s. GlaxoSmithKline’s Boostrix vaccine is said to be able to protect the elderly from diphtheria, tetanus and pertussis (whooping cough). The vaccine was originally approved for use in adolescents in 2005. Prior to this vaccine […]
FDA Unveils Flu Vaccines for 2011-12 Season
From US News, Health Day MONDAY, July 18 (HealthDay News) — Influenza may be far from most Americans’ thoughts as much of the nation wilts under oppressive heat, but the U.S. Food and Drug Administration said Monday that it’s already preparing for the 2011-12 flu season. The FDA said it has approved the vaccine formulation […]
FDA Complicit in drug fatalities
From the Office of Medical and Scientific Justice Since 2004, the pharmaceutical industry has paid $9 billion to settle thousands of criminal and civil complaints related to the illegal marketing of drugs that kill or injure a million Americans EVERY YEAR from adverse drug reactions (ADRs). Attorney Jonathan W. Emord provides an overview of the […]
FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies
From FierceBiotech Part of agency’s efforts to promote development of personalized medicines and diagnostics. The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive […]
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