A top U.S. regulator is discrediting research published a year ago that found impurities in dozens of generic heart drugs made overseas, saying the investigators contaminated the samples during their testing.
Drugmakers may win approval from U.S. regulators for “breakthrough” therapies after a single round of studies, rather than three, in an effort to speed them to patients, a Food and Drug Administration official said.
Half of the 21 drugs pulled from the market in the U.S. for safety reasons since 1995 involved heart complications, a finding that is spurring Congress and doctors to call for closer government review of side effects.
The Food and Drug Administration is weighing whether to let consumers buy medicines for some chronic conditions without a prescription while speeding approvals of drugs for infection, Alzheimer’s disease and rare conditions.
April Hauge, a nurse practitioner in Weimar, California, spent $500 on a genetic test for her autistic son in 2009 that led to purchasing thousands of dollars in vitamins and supplements. Impressed with the results, she’s now selling advice on the approach to others.
Drug cocktails for cancer, heart disease and other conditions may reach the U.S. market sooner under new guidelines that let companies seek approval for a combination of two or more medicines at the same time.