PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: GTCbio - Biopharmaceutical Conference

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Frank Sasinowski to Speak on Regulatory Issues At Orphan Drugs Conference on February 20-21, 2014 in San Diego, California - Frank Sasinowski will speak about orphan drugs approved under the FDA’s Subpart H at the second annual Orphan Drugs Research & Commercialization Conference, to be held February 20-21, 2014 in San Diego, CA - GTCbio.com
Frank Sasinowski to Speak on Regulatory Issues At Orphan Drugs Conference on February 20-21, 2014 in San Diego, California

 

NewswireToday - /newswire/ - Monrovia, CA, United States, 2013/11/29 - Frank Sasinowski will speak about orphan drugs approved under the FDA’s Subpart H at the second annual Orphan Drugs Research & Commercialization Conference, to be held February 20-21, 2014 in San Diego, CA - GTCbio.com.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

The presentation will provide an analysis of the 19 non-cancer, non-HIV drugs approved via the Subpart H pathway since the pathway’s inception. The analysis was submitted on August 26, 2013 as a comment to FDA’s July 2013 Draft Guidance on “Expedited Programs for Serious Conditions,” and showed that FDA exercised a great deal of flexibility in its review of those drugs. Dr. Sasinowski will discuss the evidentiary foundation for FDA’s determinations that a surrogate or clinical endpoint that was not validated was “reasonably likely to predict” patient benefit sufficient to meet statutory standard of substantial evidence of effectiveness.

Dr. Sasinowski is currently Director at Hyman, Phelps & McNamara, where he assists sponsors in developing new medicines and securing FDA approval for hundreds of new drugs that are often for serious and/or rare diseases. He was previously with the FDA, and was key in implementing the 1983 Orphan Drug Act. In May 2013, the National Organization for Rare Disorders (NORD) awarded Dr. Sasinowski with its first ever Lifetime Achievement Award. He was elected to NORD’s Board of Directors in 2000, and remains on the Board today.

The Orphan Drugs Research & Commercialization Conference is a forum for various stakeholders in the community to gather and share complementary perspectives on the challenges in the field and paths forward. The meeting includes presentations on the latest scientific therapeutics, panel discussions on patient registries and advocacy, networking sessions, and much more.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: GTCbio - Biopharmaceutical Conference

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


Frank Sasinowski to Speak on Regulatory Issues At Orphan Drugs Conference on February 20-21, 2014 in San Diego, California

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: GTCbio.com 
626-256-6405 infogtcbio[.]gtcbio.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any GTCbio - Biopharmaceutical Conference securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From GTCbio - Biopharmaceutical Conference / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

First European Patients Treated with DC Bead LUMI™ Radiopaque Drug-Eluting Beads
FDA Approves Genentech’s Lucentis (Ranibizumab Injection) for Diabetic Retinopathy
Biopharmaceutical Analytical Instrumentation Market Garners Strong Opportunities from Double-digit Growth in Biosimilars Finds Frost & Sullivan
BD Completes Acquisition of Caesarea Medical Electronics
MDxHealth and Ghent University Ink Licensing and Collaboration Agreements to Develop Cancer Biomarker Visualization Technology
Ipsen Completes Acquisition of ONIVYDE® (irinotecan liposome injection) and Additional Oncology Assets from Merrimack Pharmaceuticals
FDA Grants Breakthrough Therapy Designation for Rituxan® (Rituximab) in Pemphigus Vulgaris
MDxHealth Signs Agreement with Lab21 to Make SelectMDx Liquid Biopsy Test Available in the United Kingdom
Greenphire Drives Global Site Adoption of Clinical Trial Payment Solutions
Ipsen Announces MHRA Approval of New Indication for Decapeptyl® for the Treatment of Pre-menopausal Women with Early Stage Breast Cancer
SelectMDx Chosen by Michigan Medicine as Pre-biopsy Diagnostic Tool in Groundbreaking US Prostate Cancer Risk Clinic
BTG Announces CE Mark Certification for DC Bead LUMI™ - The First Commercially Available Radiopaque Drug-Eluting Bead
Sartorius to Acquire Real-time Live-cell Analysis Pioneer and Leader Essen BioScience
Pyxis™ ES System to Help U.S. Department of Defense Advance Medication Safety and Patient Care
BTG Receives U.S. FDA 510(k) Clearance for EKOS® Control Unit 4.0

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  NAKIVO, Inc.

Visit  BizJobs.com





 
  ©2017 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)