Staff Writer

6
Apr

FDA Approved an IND for Zika Virus

U.S. Food and Drug Administration An IND Approved for Zika Virus The US FDA recently approved an investigational new drug application (IND)* for a test to screen blood donations for Zika virus.  The test is manufactured by Roche Molecular Systems, Inc. (Roche). *: The IND regulations 21 CFR Part 312 (downloadable in PDF here) provides procedures and requirements governing the use of

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24
Mar

Don't Hesitate to Say I Am Sorry After Medical Errors

A woman patient, Deborah Craven (60) is now suing prominent surgeons and the Yale University Hospital in New Haven, CT after receiving a wrong operation, removing the wrong body part (rib).  The patient ended up getting two surgeries in one day. Her lawyer states she is suing because she never heard the two words “I am sorry.” Read more from CNN

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23
Mar

US Congressman Sent a Letter to Veterans Affairs Not to Allow Essure

Hon. Mike Fitzpatrick Sent a Letter to the Veterans Affairs and Related Agencies Not to Purchase Medical Device Essure March 1, 2016 The Honorable Charlie Dent Chairman Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC-227 The Capitol Washington, DC 20515 The Honorable Sanford Bishop, Jr. Ranking Member Subcommittee on Military Construction, Veterans Affairs and Related Agencies HVC- 227

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19
Mar

US FDA and Health Canada Audit Program Status for ISO 13485

The United States Food and Drug Administration (FDA) The Center for Devices and Radiological Health (CDRH) Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program The FDA/CDRH is terminating Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program. FDA will no longer accept ISO 13485:2003 voluntary audit reports with an audit end date of April 1, 2016

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15
Mar

Definitions for Medical Device Safety and Effectiveness

Safety, Effectiveness and Valid Scientific Evidence for Medical Devices Pursuant to the FDA regulations under 21 CFR Part 860, the following terms are defined. Safety There is reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and

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2
Feb

US Federal Healthcare Laws for Fraud and Abuse

The United States Statutes and Regulations for Healthcare Fraud and Abuse The Anti-Kickback Statute 42 U.S.C. § 1320a–7b(b) Safe Harbor Regulations: 42 C.F.R. § 1001.952 Listen to the US DHHS OIG’s Presentation about the Anti-Kickback Statute [youtube_advanced url=”https://www.youtube.com/watch?v=a4KhqqeAaUg” controls=”no” loop=”yes” rel=”no” modestbranding=”yes”] The False Claims Act (FCA) 31 U.S.C. §§ 3729-3733 Listen to the US DHHS OIG’s Presentation about the

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31
Jan

FDA Drug Information on Progesterone

Regulatory Status Information for Drug Progesterone FDA Approved Drugs (Drug Name and Active Ingredients) AMEN: MEDROXYPROGESTERONE ACETATE by AMARIN PHARMS CRINONE: PROGESTERONE – Vaginal Gel by ACTAVIS LABS UT INC CURRETAB: MEDROXYPROGESTERONE ACETATE – Oral Tablet by SOLVAY (Discontinued) CYCRIN: MEDROXYPROGESTERONE ACETATE – Oral Tablet by ESI (Discontinued) DELALUTIN: HYDROXYPROGESTERONE CAPROATE – Injectable/Injection by BRISTOL MYERS SQUIBB (Discontinued) DEPO-PROVERA: MEDROXYPROGESTERONE ACETATE – Injectable/Injection (150

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14
Jan

FDA Needs to Improve Oversight of Postapproval Data

United States Government Accountability Office (GAO) The following report is published dated December 15, 2015 and released to the public on January 14, 2016 Report to the Ranking Member, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations, House of Representatives DRUG SAFETY FDA Expedites Many Applications, But Data for Postapproval Oversight Need From October

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13
Jan

FDA UDI Final Rule

Food and Drug Administration The Unique Device Identification (UDI) Final Rule On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule).  The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies. The rule will be

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30
Dec

Proposed Final Documents for Medical Device Harmonization in Asia

Asian Harmonization Working Party (AHWP) AHWP is established as a non-profit organization. Its goals are to study and recommend ways to harmonize medical device regulations in the Asian and other regions. AHWP recently issued PROPOSED Final Documents for medical device harmonization in Asian countries. AHWP’s PROPOSED Final Documents Common Submission Dossier Template (CSDT) [download id=”22589″] 2015 CSDT is also available here.

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