Tag: Drugs

3
Jun

Global Adverse Event Databases

The United States Food and Drug Administration Mandatory Reporting According to Applicable Regulations Drugs and Biologics Drugs – FDA Adverse Event Reporting System (FAERS) Data Files Devices Medical Devices – MAUDE (Manufacturer and User Facility Device Experience) Vaccine Adverse Event Reporting System Australia – Therapeutic Goods Administration Database of Adverse Event Notifications (DAEN) The Therapeutic Goods Administration (TGA) receives adverse event reports associated with

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7
Oct

FDA Biomarker Qualification Program A Formal Process

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) Under FDA/CDER’s work, FDA has established the Biomarker Qualification Program (BQP), intending to develop biomarkers with external scientists. The BQP offers a formal process to guide submitters as they develop biomarkers and rigorously evaluate them for use in the regulatory process. The goals of the CDER BQP are to: Provide a framework

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16
Aug

India CDSCO: Regulatory Information for Medical Devices and Drugs

India Central Drugs Standard Control Organization (CDSCO) By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) Medical Devices and Diagnostic Division You may visit India CDSCO’s Medical Device Division here. List of Notified Medical Devices and Guidelines of Import and Manufacture of Medical Devices [members] India CDSCO List of Notified Medical Devices Clearification on Guidelines of Import and Manufacture of Medical

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1
Aug

FDA’s Drug Approval Process Is Now Faster Than Anywhere Else In the World

By Admin Dr. Janet Woodcock, M.D., before the Subcommittee on Health, House Committee on Energy and Commerce She stated: FDA’s approval process is now faster than anywhere else in the world (see figure below). Just last year, three-quarters of the new drugs FDA approved were approved in the United States before the European Union (EU) and Japan. Currently 90 percent of drugs

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1
Nov

FDA First Breakthrough Therapy Drug Gazyva

FDA’s First Breakthrough Therapy Drug: Gazyva FDA approves Gazyva for chronic lymphocytic leukemia Drug is first with breakthrough therapy designation to receive FDA approval The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab). Gazyva Indications and Usage GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic

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1
Nov

Novel Oral Anticoagulants NOACs)and Risk of Bleeding

Novel Oral Anticoagulants (NOACs) and Risk of Bleeding By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 24, 2014 IMB | Novel Oral Anticoagulants (NOACs) and Risk of Bleeding In the drug safety news issued by the Irish Medicines Board (IMB), it is revealed that there are three NOACs licensed for use in Ireland and across the EU

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24
Oct

US FDA Drug Promotion Information

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (Regulatory Doctor LinkedIn Google Plus Twitter Facebook Tumblr) and Updated on December 28, 2014 Presentation of Quantitative Benefit Information in Direct-to-Consumer (DTC) Television and Print Advertisements for Prescription Drugs: A Randomized Study Final Technical Report FDA is committed to fostering the safe and effective use of prescription drugs and believes that improvement in peoples’ understanding of risk

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1
Oct

Perjeta | The First Biotech Breast Cancer Drug Approved

Perjeta | The First Biotech Pre-Surgical Breast Cancer Drug Approved FDA approves Perjeta for neoadjuvant breast cancer treatment Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute. Almost 20 percent of breast cancers

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28
Sep

EU Human Drugs MRP and DP Templates

Mutual Recognition Procedure (MRP) and Decentralized Procedure (DP) By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) EU Human Drugs | Mutual Recognition Procedure (MRP) and Decentralized Procedure (DP) Templates     Read About CMDh Rules of Procedure here. List of guidance documents published by CMDh here. Applications for Marketing Authorisation Template: Cover letter for new applications submitted through MRP/DCP (January 2012) (WORD) Template: Letter

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20
Sep

Global Medical Products