Staff Writer

28
Dec

FCC Provides Ten Cybersecurity Tips for Small Businesses

Federal Communications Commission (FCC) A recent study found that having a broadband connection makes a $200,000 a year difference in median annual revenues for businesses, by reaching new markets and increasing productivity. The FCC released a Cybersecurity Tip Sheet, which outlines the top ten ways entrepreneurs can protect their companies – and customers – from cyberattack. Cybersecurity Roundtable: Protecting Small Businesses [youtube_advanced

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18
Dec

First Insulin Glargine Similar to Lantus Approved Under 505b2 Pathway

The U.S. Food and Drug Administration (FDA) Basaglar (insulin glargine injection) A long-acting human insulin analog The FDA approved Basaglar to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2

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18
Dec

FDA Proposes Restricted Use and Special Controls of Sunlamp Products

Food and Drug Administration (FDA) FDA Proposes Two Rules: 1). to Restrict Sale, Distribution, and Use of Sunlamp Products including 2). Amendment to Performance Standard.  On December 18, 2015, the U.S. FDA announced important proposed steps ‎to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of

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16
Dec

First of Kind Military Wound Dressing Cleared for Civilian Use

Food and Drug Administration (FDA) Clearance for Traumatic Wound Dressing XSTAT 30 Wound Dressing FDA clears military traumatic wound dressing for use in the civilian population FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin

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12
Dec

OSHA Fines to Significantly Rise for The First Time Since 1990

Occupational Safety and Health Administration (OSHA) With the Occupational Safety and Health Act of 1970, Congress created the OSHA to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. Bipartisan Budget Act of 2015 11/02/2015 Became Public Law No: 114-74 According to the Bipartisan Budget Act, signed

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11
Dec

Regulatory History for Bionic Eye Retinal Prosthesis System

Argus II – Retinal Implant Bionic Eye – Retinal Prosthesis System World’s First Artificial Retina Feasibility Study Protocol: NCT00407602 First received: December 1, 2006 The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with severe to profound retinitis pigmentosa. Primary Outcome Measures

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9
Dec

FDA PMA and BLA for APLIGRAF and GINTUIT

Class III Medical Device and Biologics License Application (BLA) Class III Medical Device APLIGRAF: P950032 Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers. Intended Use/Indications Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full

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9
Dec

Would Care Wound and Burn Dressing PMAs

Wound and Burn Dressing Summary of Regulatory Approval Pathways Class III Device PMA Combination Product Product Code:  MGR PMA Devices 1). Integra Dermal Regeneration Template: P900033 (a device to treat the skin of people with severe burns) INTEGRA® Dermal Regeneration Template is a device to treat the skin of people with severe burns. FDA has recently expanded the approved use of this

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7
Dec

Diabetes Vascular Disease and Wound Care Products

Diabetes-Related Vascular and Wound Care Products FDA Approved Medical Products Drugs PLAVIX Plavix is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], Plavix has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate

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4
Dec

FDA Approved Pediatric Cancer Drugs

FDA Approved Cancer Drugs Oncology Drugs for Pediatric Patients During the Past Decades Teniposide (1992-07-14) Drug Name:  VUMON FDA Application No.: (NDA) 020119 Active Ingredient: TENIPOSIDE Teniposide Injection, in combination with other approved anticancer agents, is indicated for induction therapy in patients with refractory childhood acute lymphoblastic leukemia (ALL). FDA Approval for Teniposide (Vumon) FDA Review History for Teniposide (Vumon) What

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