- published: 10 Nov 2011
- views: 7605
- author: TheEmergoGroup
7:45

US FDA medical device regulatory approval process overview
Provides a short high level overview of the US FDA medical device regulatory approval proc...
published: 10 Nov 2011
author: TheEmergoGroup
US FDA medical device regulatory approval process overview
US FDA medical device regulatory approval process overview
Provides a short high level overview of the US FDA medical device regulatory approval process. Talks about device classification, 510(k) applications, GMP qu...- published: 10 Nov 2011
- views: 7605
- author: TheEmergoGroup
4:55

Dinesh Thakur on Ranbaxy US FDA case
Dinesh Thakur, former Ranbaxy director and the whistle in the case, speaks to Mint about t...
published: 22 May 2013
author: livemintvideos
Dinesh Thakur on Ranbaxy US FDA case
Dinesh Thakur on Ranbaxy US FDA case
Dinesh Thakur, former Ranbaxy director and the whistle in the case, speaks to Mint about the implications of the order for the Indian generic drug industry. ...- published: 22 May 2013
- views: 606
- author: livemintvideos
3:46

U.S. FDA Food Labeling Regulations (English)
Registrar Corp assists companies with U.S. FDA Food Labeling regulations. For immediate as...
published: 22 Mar 2012
author: David Lennarz
U.S. FDA Food Labeling Regulations (English)
U.S. FDA Food Labeling Regulations (English)
Registrar Corp assists companies with U.S. FDA Food Labeling regulations. For immediate assistance: http://www.registrarcorp.com/livehelp -------------------...- published: 22 Mar 2012
- views: 120095
- author: David Lennarz
1:57

US FDA inspections in India to increase
In response to CNBC TV18 queries, US FDA said foreign inspections are going to increase as...
published: 02 Jul 2013
author: moneycontrol
US FDA inspections in India to increase
US FDA inspections in India to increase
In response to CNBC TV18 queries, US FDA said foreign inspections are going to increase as number of US FDA registered plants outside of US have increased, a...- published: 02 Jul 2013
- views: 31
- author: moneycontrol
5:20

U.S. FDA Food Facility Registration
Registrar Corp assists companies with U.S. FDA Food Facility Registration regulations. For...
published: 16 May 2012
author: David Lennarz
U.S. FDA Food Facility Registration
U.S. FDA Food Facility Registration
Registrar Corp assists companies with U.S. FDA Food Facility Registration regulations. For immediate assistance: http://www.registrarcorp.com/livehelp ------...- published: 16 May 2012
- views: 122860
- author: David Lennarz
3:01

U.S. FDA Food Facility Registration Renewal
Registrar Corp assists companies with U.S. FDA Food Facility Registration regulations. For...
published: 11 Oct 2012
author: David Lennarz
U.S. FDA Food Facility Registration Renewal
U.S. FDA Food Facility Registration Renewal
Registrar Corp assists companies with U.S. FDA Food Facility Registration regulations. For immediate assistance: http://www.registrarcorp.com/livehelp ------...- published: 11 Oct 2012
- views: 116551
- author: David Lennarz
1:54

In Business - USFDA Import Hit For Ranbaxy
The USFDA has issued an import alert against Ranbaxy and says that it will not be able to ...
published: 16 Sep 2013
In Business - USFDA Import Hit For Ranbaxy
In Business - USFDA Import Hit For Ranbaxy
The USFDA has issued an import alert against Ranbaxy and says that it will not be able to import drugs produced at its Mohali unit. While the order does not have a significant financial impact on the company, it has dampened sentiment as the unit was being primed for new launches. Bloomberg TV India discusses how this ban raises doubts about the launch of some of the company's key exclusive drugs.- published: 16 Sep 2013
- views: 1
51:02

The US FDA 510(k) Medical Registration Process
Overview of the US FDA 510(k) process for medical device registration in the US. Download ...
published: 17 Oct 2012
author: TheEmergoGroup
The US FDA 510(k) Medical Registration Process
The US FDA 510(k) Medical Registration Process
Overview of the US FDA 510(k) process for medical device registration in the US. Download the webinar files here http://goo.gl/kDEKP or read more about our F...- published: 17 Oct 2012
- views: 747
- author: TheEmergoGroup
1:43

US FDA bans imports from Ranbaxy's Mohali plant
Read the full story at http://ibnlive.in.com/news/us-fda-bans-imports-from-ranbaxys-mohali...
published: 16 Sep 2013
US FDA bans imports from Ranbaxy's Mohali plant
US FDA bans imports from Ranbaxy's Mohali plant
Read the full story at http://ibnlive.in.com/news/us-fda-bans-imports-from-ranbaxys-mohali-plant/422383-7.html The US Food and Drug Administration has issued an import alert against drugs manufactured at Ranbaxy's Mohali plant in Punjab over quality concerns. This means Ranbaxy will not be able to ship drugs manufactured at the plant to the US until the ban is lifted. This is the third alert against Ranbaxy. Warnings have been earlier issued against its plants in Paonta and Dewas. Ranbaxy, however, said it has not received any such warning.- published: 16 Sep 2013
- views: 27
2:33

US FDA Examining Failures of LASIK Eye Surgery
LASIK eye surgery is used to correct people's vision and end their need for glasses or con...
published: 03 Mar 2010
author: VOAvideo
US FDA Examining Failures of LASIK Eye Surgery
US FDA Examining Failures of LASIK Eye Surgery
LASIK eye surgery is used to correct people's vision and end their need for glasses or contact lenses. The US Food and Drug Administration approved the proce...- published: 03 Mar 2010
- views: 3558
- author: VOAvideo
2:00

Introduction to the US Food and Drug Administration (FDA) by RPN
Regulatory Pharma Net, S.L. (RPN) prepared this video as a short introduction for its Food...
published: 10 Apr 2010
author: RegulatoryPharmaNet
Introduction to the US Food and Drug Administration (FDA) by RPN
Introduction to the US Food and Drug Administration (FDA) by RPN
Regulatory Pharma Net, S.L. (RPN) prepared this video as a short introduction for its Food and Drug Administration (FDA) Open Seminar Getting started in the ...- published: 10 Apr 2010
- views: 1630
- author: RegulatoryPharmaNet
10:01

U.S. FDA EXPORT REGULATIONS - Part 4: Food Labeling Requirements & Voluntary Organizations
September 6, 2011 - World Bank, Washington, DC David Lennarz of Registrar Corp and the Asi...
published: 29 Sep 2011
author: RegistrarCorpUS
U.S. FDA EXPORT REGULATIONS - Part 4: Food Labeling Requirements & Voluntary Organizations
U.S. FDA EXPORT REGULATIONS - Part 4: Food Labeling Requirements & Voluntary Organizations
September 6, 2011 - World Bank, Washington, DC David Lennarz of Registrar Corp and the Asian Productivity Organization hosted an international broadcast on U...- published: 29 Sep 2011
- views: 432
- author: RegistrarCorpUS
2:25

USFDA issues import alert for Ranbaxy Mohali facilities
In a major blow to Ranbaxy Laboratories, USFDA has imposed a ban against its Mohali facili...
published: 16 Sep 2013
USFDA issues import alert for Ranbaxy Mohali facilities
USFDA issues import alert for Ranbaxy Mohali facilities
In a major blow to Ranbaxy Laboratories, USFDA has imposed a ban against its Mohali facilities. This ban is likely to impact Ranbaxy's export plans. Mint's CH Unnikrishnan has more on this- published: 16 Sep 2013
- views: 27
4:31

U.S. FDA EXPORT REGULATIONS - Part 1: U.S. FDA Jurisdiction & Requirements Overview
September 6, 2011 - World Bank, Washington, DC David Lennarz of Registrar Corp and the Asi...
published: 29 Sep 2011
author: RegistrarCorpUS
U.S. FDA EXPORT REGULATIONS - Part 1: U.S. FDA Jurisdiction & Requirements Overview
U.S. FDA EXPORT REGULATIONS - Part 1: U.S. FDA Jurisdiction & Requirements Overview
September 6, 2011 - World Bank, Washington, DC David Lennarz of Registrar Corp and the Asian Productivity Organization host an international broadcast on U.S...- published: 29 Sep 2011
- views: 551
- author: RegistrarCorpUS
Youtube results:
2:32

USFDA enters India
The USFDA is here in Mumbai for good. The Indian division met members of India's pharmaceu...
published: 31 Jul 2009
author: utvinews
USFDA enters India
USFDA enters India
The USFDA is here in Mumbai for good. The Indian division met members of India's pharmaceutical community today to discuss its role here in India.- published: 31 Jul 2009
- views: 772
- author: utvinews
5:27

U.S. FDA EXPORT REGULATIONS - Part 5: Food Safety Modernization Act (FSMA)
September 6, 2011 - World Bank, Washington, DC David Lennarz of Registrar Corp and the Asi...
published: 30 Sep 2011
author: RegistrarCorpUS
U.S. FDA EXPORT REGULATIONS - Part 5: Food Safety Modernization Act (FSMA)
U.S. FDA EXPORT REGULATIONS - Part 5: Food Safety Modernization Act (FSMA)
September 6, 2011 - World Bank, Washington, DC David Lennarz of Registrar Corp and the Asian Productivity Organization hosted an international broadcast on U...- published: 30 Sep 2011
- views: 302
- author: RegistrarCorpUS
1:06

Hospira (HSP) U.S. FDA Approval of Solution Version of Gemcitabine Injection - CRWENewswire.com
Thank you for joining us. I am your host Sara Bryant at CRWE Newswire Stocks to watch Hosp...
published: 06 Aug 2011
author: CRWE Newswire
Hospira (HSP) U.S. FDA Approval of Solution Version of Gemcitabine Injection - CRWENewswire.com
Hospira (HSP) U.S. FDA Approval of Solution Version of Gemcitabine Injection - CRWENewswire.com
Thank you for joining us. I am your host Sara Bryant at CRWE Newswire Stocks to watch Hospira, Incorporated - symbol HSP - reported U.S. Food and Drug Admini...- published: 06 Aug 2011
- views: 285
- author: CRWE Newswire
1:16

US FDA 510(k): Preparation, Submission and Clearance
About the 510(k) Seminar
Presented by Dr. David Lim and Hosted by Global Compliance Semi...
published: 14 Oct 2013
US FDA 510(k): Preparation, Submission and Clearance
US FDA 510(k): Preparation, Submission and Clearance
About the 510(k) Seminar Presented by Dr. David Lim and Hosted by Global Compliance Seminar at http://www.GlobalComplianceSeminar.com The speaker (http://www.regulatorydoctor.com) will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C; Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance. In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance. To inquire about a 510(k) LIVE online seminar/webinar or 510(k) consulting services, please contact us at http://www.regulatorydoctor.com or http://www.globalcomplianceseminar.com. Otherwise, you can email us at info@regulatorydoctor.com- published: 14 Oct 2013
- views: 15