Regulatory Doctor

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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3
Dec

Apply for FDA Patient Representative Program

United States Food and Drug Administration (FDA) About the Patient Representative Program The FDA is committed to making more opportunities for patients to participate in FDA decision-making. The FDA recruits Patient Representatives on an as-needed basis to: Help advise us on drugs, devices, and biologics that are currently being considered for approval Give us input earlier in the regulatory medical product

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27
Nov

Learn about Tumor Necrosis Factor Blockers

Tumor Necrosis Factor (TNF) Blockers TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases, such as: Crohn’s disease ulcerative colitis rheumatoid arthritis ankylosing spondylitis psoriatic arthritis plaque psoriasis. The drugs in this class include: Remicade (infliximab) Enbrel (etanercept) Humira (adalimumab) Cimzia (certolizumab pegol)

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17
Nov

The Role of Emotional Intelligence in Physician and Organizational Success

Becker’s Hospital Review Presents the Following Educational Video [youtube_advanced url=”https://www.youtube.com/watch?v=vlNlDVNoC7g” controls=”no” autoplay=”yes” rel=”no” modestbranding=”yes”] [button url=”http://globalcomplianceseminar.com” target=”blank” style=”3d” background=”#c91119″ size=”10″ wide=”yes” center=”yes”]Learn here about FDA training seminars[/button] Last Updated: 2015-11-19

14
Nov

A Breakthrough Clinical Trial for Uterus Transplant

The First Clinical Trial for Uterus Transplant Uterine Transplantation for the Treatment of Uterine Factor Infertility [youtube_advanced url=”https://www.youtube.com/watch?v=GfPcB6elcXA” controls=”no” autoplay=”yes” rel=”no” modestbranding=”yes”] The Cleveland Clinic (study sponsor) is recruiting participants in a clinical trial for feasibility study, entitled “Uterine Transplantation for the Treatment of Uterine Factor Infertility.” In the feasibility study, the study sponsor aims to enroll ten (10) subjects

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13
Nov

FDA Orders a Firm to Recall All of Its Automated Endoscope Reprocessors

FDA Orders Recall The Order is Under Consent Decree for All Custom Ultrasonics Automated Endoscope Reprocessors (AERs) November 13, 2015 The U.S. Food and Drug Administration (FDA) ordered Custom Ultrasonics to recall all (an estimate of 2,800) of its automated endoscope reprocessors (AERs) currently in hospitals and outpatient clinics throughout the United States.  FDA’s order is due to the firm’s

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12
Nov

FDA CDRH MDUFA III Performance Report

The United States Food and Drug Administration (FDA) The Center for Devices and Radiological Health (CDRH) MDUFA III (FY 2013-2017) Performance Report for 4th Quarter of FY 2015 November 9, 2015 Table of Contents Section 1: PMA Originals and Panel Track Supplements DAGRID Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices DCD Division of Cardiovascular Devices DCTD Division

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