This article was originally published in The Gray Sheet
FDA approves Advanced Medical Optics' PMA for CustomVue Monovision LASIK, the first system to allow laser treatment of one eye for distance vision and the other eye for close-up vision, the agency announces July 12. AMO acquired the device through its 2005 purchase of VISX. The company needs to conduct a 500-patient post-approval study assessing patients six months following surgery for visual disturbances...
You may also be interested in...
A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule.
Companies across Europe are dealing with new challenges stemming from the coronavirus outbreak, particularly with supply issues due to increased demand. This article details the responses of five consumer health players in the region: Reckitt Benckiser, Zentiva, Vitabiotics, Alliance Pharma and BioGaia.
As the global shut-down caused by the coronavirus pandemic continues, sponsors are rushing to adapt clinical trials that can move to partial or completely remote monitoring, allowing patients to remain in their homes but continue to participate in studies. And the outbreak may have another silver lining for the biopharma industry, a chance to rebuild its reputation.