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Publication Exclusive: Experts ponder drug compounding law’s impact on ophthalmology

May 26, 2015

In 2013, in the wake of infectious outbreaks traced to steroids and repackaged intravitreal Avastin produced at compounding pharmacies, Congress passed the Drug Quality and Security Act, which included the Compounding Quality Act. The law gives the FDA new authorities to regulate the activities of compounding pharmacies, drug repackagers and a new class of “outsourcing manufacturers.”

In subsequent guidance documents, the FDA clarified various requirements regarding the activities of traditional compounders, such as the need to receive a patient-specific prescription for each compounded drug. In a set of draft guidance documents issued in February, the FDA made recommendations on outsourcing facilities, mixing and repackaging, and interstate shipping. Some experts see some of the recommendations as a plus, while others have a less optimistic view.

BLOG: Refixation of a decentered IOL BlogVideo

BLOG: Refixation of a decentered IOL

May 25, 2015
Proper centration of an IOL is essential to optimize visual outcomes, and the scenario is challenging when there is an associated posterior capsule rupture. Refixation…
VIDEO: Combination therapy better manages postop inflammation Meeting News CoverageVideo

VIDEO: Combination therapy better manages postop inflammation

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MILAN — At the OSN Italy meeting, Luigi Fontana, MD, talks about postoperative management of inflammation after cataract surgery. In a single center randomized clinical…
Business News

Spark Therapeutics reports $2.3 million in revenue in first quarter

May 25, 2015
Spark Therapeutics, developer of SPK-RPE65, a potential gene therapy treatment for RPE65-mediated inherited retinal degenerations, reported $2.3 million in revenue in…
VIDEO: Update on microinvasive glaucoma procedures Meeting News CoverageVideo

VIDEO: Update on microinvasive glaucoma procedures

May 24, 2015
MILAN — At the OSN Italy meeting, E. Randy Craven, MD, talks about microinvasive glaucoma procedures, specifically focusing on microstents and the option of using two…
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Practical Retina

Comparing Aflibercept, Bevacizumab, and Ranibizumab for DME: Analysis of DRCR Protocol T

Ophthalmic Surgery, Lasers and Imaging Retina, March 2015, Volume 46 Issue 3
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CME
Gaining Insight to Optimize Patient Outcomes: What Can We Do to Improve Postoperative Inflammation and Pain?

Gaining Insight to Optimize Patient Outcomes: What Can We Do to Improve Postoperative Inflammation and Pain?

This activity is supported by an educational grant from Bausch + Lomb.

Postoperative pain and inflammation can result as a consequence of cataract surgery despite advances in surgical…
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Meeting News Coverage Video
VIDEO: Update on microinvasive glaucoma procedures

VIDEO: Update on microinvasive glaucoma procedures

May 24, 2015
MILAN — At the OSN Italy meeting, E. Randy Craven, MD, talks about microinvasive glaucoma procedures, specifically…
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