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July2015
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503b CompoundingFDA Finalizes Six-Month Drug Shortage Notice Regulation
From the Regulatory Affairs Professionals Society (RAPS) June 8, 2015 By Michael Mezher A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages. Background In 2011, after several years of worsening […]
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June2015
FDA Releases New Guidance for Compounding Animal Drugs from Bulk Drug Substances
June 24, 2015 Animal Compounders Fear the End is Near & Begin to Fight Their Losing Battle A few weeks ago the FDA released their latest guidance, #230 Guidance for Industry Compounding Animal Drugs from Bulk Drug Substances and animal compounders are very concerned at what this means for their futures. All guidances reflect the […]
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June2015
category:
503b CompoundingOphthalmologists and Patients Demand Quality Compounded Drugs at Affordable Prices
Access to compounding medications critical for ophthalmologists, patients http://www.healio.com/ophthalmology/practice-management/news/print/ocular-surgery-news/%7Bebef4371-1c0c-460d-b3cb-6e8d524915e2%7D/access-to-compounded-medications-critical-for-ophthalmologists-patients?page=1 Ocular Surgery News U.S. Edition, May 25, 2015 Richard L. Lindstrom, MD The decisions the FDA makes are critical to ophthalmologists and patients, especially in the anti-VEGF category. As I mentioned above, no generic anti-VEGF injectables are available. Lucentis (ranibizumab, Genentech) and Eylea, branded and patent-protected […]
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