Navigation Links
FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014

Falls Church, VA (PRWEB) July 18, 2014

Choosing the Right Drug Name:
How to Increase Your Chances for Approval
**FDAnews Webinar**
July 22, 2014 — 1:30 p.m. – 3:00 p.m. EDT

The FDA rejects 40% of the drug names presented to it each year.

Not surprisingly, the drug industry has long criticized the agency about its name approval process.

So, in May 2014, the FDA released a draft guidance that covers the selection and approval process for proposed names of both prescription and nonprescription human drugs and biologics. In the guidance, the FDA describes its own review processes in detail and lays out 4 steps a company should follow in choosing a drug name.

To address this issue, FDAnews has teamed with drug-naming expert Dr. Susan Proulx to present a 90-minute webinar that will look closely at the draft guidance and its recommended 4-step process. Dr. Proulx will provide ideas on how to win the FDA’s approval for a suggested drug name.

BONUS HANDOUT: Attendees will receive their own copy of a chart that compares drug name approval regulations in the US and Canada.

And attendees will learn more about the following:

  •     How the new guidance will impact on drug trademark development (in time, money, and the differences from country to country that affect processing for a global mark)
  •     Pros and cons of relying on computerized searching to identify similarity in proposed names
  •     Using simulation testing ; how to conduct testing similar to what the FDA will eventually do on the chosen drug name
  •     The need for expert analysis before deciding what trademark to choose

Meet the Presenter:
Over the course of her career in Medication Safety, Dr. Susan Proulx has become an expert in all aspects of product-related safety issues. In addition to being a leader in the industry in preventing medication errors due to trademark confusion, she also has overseen numerous projects related to improvement of packaging and labels to increase clarity and ease of reading.

Who Will Benefit:

  •     Strategic planning and business development staff
  •     Marketing, sales and advertising personnel
  •     Compliance officers
  •     Risk management specialists
  •     Consultants/service providers
  •     Executive management
  •     General/corporate counsel
  •     R&D staff
  •     Regulatory/legislative affairs professionals

Webinar Details:
Choosing the Right Drug Name:
How to Increase Your Chances for Approval
**FDAnews Webinar**
July 22, 2014 — 1:30 p.m. – 3:00 p.m. EDT

$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at

Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Related medicine news :

1. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
2. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Management Report: Implementing Risk-Based Verification and Validation
5. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
6. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
7. Announces Hurricane Season Special Offers on their Complete Line of Accordion Hurricane Shutters
8. Sharon Kleyne Hour Power of Water Announces International Water Conference in Bulgaria
9. Valued Pharmacy Services Announces Joint Venture With Truveris
10. First Choice Emergency Room Announces Dr. Gorav Bohil as Medical Director of Southeast Allen Facility
11. South Portland Marijuana Doctor Announces Grand Opening of New Alternative Practice in Maine
Post Your Comments:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer ... through a fitness app. The fitness app plans to fix the two major problems leading ... a one size fits all type program , They don’t eliminate all the ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set of ... or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, Serenity ... event. , Trauma sufferers tend to feel a range of emotions, from depression, guilt, ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 The Academy ... of recommendations that would allow biopharmaceutical companies ... with entities that make formulary and coverage decisions, a ... "value" of new medicines. The recommendations address ... not appear on the drug label, a prohibition that ...
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
Breaking Medicine Technology: