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FDA issues draft guidance on nonproprietary naming of biologics, biosimilars

August 27, 2015

The FDA today announced the availability of a draft guidance describing its proposal on the nonproprietary naming of biological products.

According to an FDA blog post by Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, and Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, the nonproprietary naming of biological products is a key issue for ensuring their safety and promoting their acceptance.

Perspectives on Glaucoma

Equivalent IOP lowering found when travoprost is preserved with polyquaternium or benzalkonium chloride

July 24, 2015
Researchers found no significant differences between the intraocular pressure-lowering efficacy of polyquaternium-1-preserved travoprost and benzalkonium…
Lindsay Gibney Meeting News Coverage

Incidence of CME high in patients with retinitis pigmentosa

July 9, 2015
SEATTLE – Up to 70% of patients with retinitis pigmentosa can have cystoid macular edema, so thorough subjective and objective testing is advised, a presenter said…
Agustin Gonzalez Meeting News CoverageVideo

VIDEO: Gonzalez: Point-of-care testing helps personalize care

July 1, 2015
SEATTLE – Agustin L. Gonzalez, OD, made several presentations here at Optometry’s Meeting, one of which discussed point-of-care testing with biomarker…
Meeting News Coverage Video
Mel Friedman

VIDEO: Carefully supervise patients when using generics

June 29, 2015
SEATTLE – Mel Friedman, OD, lectured on three topics here at Optometry’s Meeting, one of which…
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Blog

BLOG: Uveitis treatment comes into the modern age

January 14, 2015
The treatment of inflammatory ocular disease is becoming more exciting. In years past, the spectrum of available…
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Perspectives on Glaucoma

Closely monitor children for steroid-induced glaucoma

June 23, 2015
Researchers recommended that eye care providers reconsider topical steroids for children as a primary treatment option…
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FDA News

FDA issues draft guidance on nonproprietary naming of biologics, biosimilars

August 27, 2015
The FDA today announced the availability of a draft guidance describing its proposal on the nonproprietary naming of biological products.According to…
Perspectives on Glaucoma

Equivalent IOP lowering found when travoprost is preserved with polyquaternium or benzalkonium chloride

July 24, 2015
Researchers found no significant differences between the intraocular pressure-lowering efficacy of polyquaternium-1-preserved travoprost and…
Lindsay Gibney Meeting News Coverage

Incidence of CME high in patients with retinitis pigmentosa

July 9, 2015
SEATTLE – Up to 70% of patients with retinitis pigmentosa can have cystoid macular edema, so thorough subjective and objective testing is…
Agustin Gonzalez Meeting News CoverageVideo

VIDEO: Gonzalez: Point-of-care testing helps personalize care

July 1, 2015
SEATTLE – Agustin L. Gonzalez, OD, made several presentations here at Optometry’s Meeting, one of which discussed point-of-care testing…
Mel Friedman Meeting News CoverageVideo

VIDEO: Carefully supervise patients when using generics

June 29, 2015
SEATTLE – Mel Friedman, OD, lectured on three topics here at Optometry’s Meeting, one of which covered  the use of brand vs. generic…
Perspectives on Glaucoma

Closely monitor children for steroid-induced glaucoma

June 23, 2015
Researchers recommended that eye care providers reconsider topical steroids for children as a primary treatment option or monitor them closely, in a…
Blog

BLOG: Cost burden of diabetic retinopathy treatment is about to explode

June 22, 2015
The Protocol T study from the Diabetic Retinopathy Clinical Research Network was funded by the NIH as a long-term evaluation to answer the question…

Eleven Biotherapeutics agent improves allergic conjunctivitis symptoms

June 19, 2015
Eleven Biotherapeutics announced that a phase 2 exploratory study of EBI-005 showed significant improvements in ocular itching and tearing and…

Growth to begin in 2016 in glaucoma treatment market

June 18, 2015
The market for glaucoma pharmaceuticals is predicted to remain flat until 2016, when growth will begin as a result of the introduction of new…
Perspectives on Glaucoma

Reduced incidence of SPK seen with newer travoprost preservative

June 17, 2015
Patients with chronic superficial punctate keratitis demonstrated improvement after switching from benzalkonium chloride-preserved latanoprost to…
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