In a letter to the U.S. Food and Drug Administration, Allergan requested that the agency revise and replace bioequivalence draft guidelines issued on June 20. The FDA accepted public comment on the proposed guidelines until Aug. 19.Richard Spivey, Allergan’s senior vice president for global regulatory affairs, objected to a proposal in the draft guidance that in vitro analysis alone may establish the bioequivalence of a generic drug to Allergan’s Restasis (cyclosporine ophthalmic suspension 0.05%).
Bausch + Lomb updates supplement to match AREDS 2 recommendations
Bausch + Lomb has begun shipping its new PreserVision AREDS 2 Formula vitamin and mineral supplement, according to a news release.The patented formula, updated to precisely match the latest clinical evidence from the National Eye Institute Age-Related …
Anterior corneal curvature, shape factor can determine posterior corneal shape in patients with keratoconus
Prediction of central posterior corneal curvature and shape factor are possible through the evaluation of anterior curvature and shape in patients with keratoconus, according to a study. The study included 61 eyes of 61 patients between the ages of 14 …
AMD associated with impaired lysosomal autophagy, study finds
A new study published in the prestigious PLoS One journal changes our understanding of the pathogenesis of age-related macular degeneration. The researchers found that degenerative changes and loss of vision are caused by impaired function of the lysos…
HIV prevention program at UCLA may reduce unprotected sex among bisexual black men
A culturally tailored HIV prevention program developed and tested by investigators at UCLA and the Charles R. Drew University of Medicine and Science has been shown to significantly reduce unprotected sex among bisexual black men.
Effects of vitamin C and D administration on mood and distress in acutely hospitalized patients
By: LJHOFFER