PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: Tiziani Whitmyre, Inc.

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!

White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers Released - A new white paper, addressing the challenges of new U.S. Food and Drug Administration (FDA) regulations awaiting combination products manufacturers, is now available for download at the link below
White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers Released

 

NewswireToday - /newswire/ - Agawam, MA, United States, 2007/12/04 - A new white paper, addressing the challenges of new U.S. Food and Drug Administration (FDA) regulations awaiting combination products manufacturers, is now available for download at the link below.

   
 
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!


 

While combination products are experiencing dramatic growth, the convergence of drug/biologics and devices brings a host of regulatory challenges. Manufacturers must ensure their products meet cGMP practices as well as pass muster with the FDA, ISO, and USP.

Steven Richter, Ph.D., Microtest President & Chief Scientific Officer, addresses the critical issues associated with this complex process, including defining the FDA’s regulatory framework, reviewing developments in FDA thinking, and identifying future considerations in developing effective quality assurance systems.
“The combination products market – medical devices embedded with pharmaceutical or biologics components –is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Richter, who is author of the announced white paper, “Combination Products: Navigating Two FDA Quality Systems.”

Navigant consulting, estimating the combination products market at $5.9 billion in 2004, predicts a nearly $9.5 billion market in 2009. In 2005, the FDA received 275 combo product submissions, and an estimated 30% of new products under development today are combo products.

“For manufacturers, the convergence of devices and drugs or biologics also brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products,” he said.

The paper’s contents include: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

For more information visit Microtest on the Web, or call toll-free: 1-800-631-1680.

About Microtest
Microtest (microtestlabs.com) is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, call 1-413-786-1680 or toll-free 1-800-631-1680

 
 
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: Tiziani Whitmyre, Inc.

 
 

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!


White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers Released

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: Brandie Gerrish 
781-793-9380 bgerrish[.]tizinc.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 Tiziani Whitmyre, Inc. 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 Tiziani Whitmyre, Inc. / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

BD Initiates New Industry Alliance to Combat Rising Opioid Crisis
BTG and Society of Interventional Oncology to Explore Role of Minimally Invasive Therapies in Immuno-oncology
Ipsen to Acquire a Portfolio of Select Consumer Healthcare Products from Sanofi
BD Announces Early Access Program for BD Resolve™ Single-Cell Analysis Platform
Precision Medicine Unlocks the Future of Targeted Therapy in the Global Healthcare Industry Finds Frost & Sullivan
Sciformix Corporation Receives Prestigious 2017 Global Outsourcing Customer Service Leadership Award from Frost & Sullivan
Arven Pharmaceuticals Selects GE Healthcare’s FlexFactory to Improve Turkish and Regional Access to Biopharmaceuticals
Ipsen to Acquire Primary Care Platform in Italy from Akkadeas Pharma
Cost-Containment and Client-Centric Services Catalyse European Custom Procedure Trays and Packs Market Finds Frost & Sullivan
New BD Institute for Medication Management Excellence Aims to Improve Patient Safety and Outcomes through Collaboration
New Varicose Vein Treatment Offers Minimally Invasive Non Surgical Procedure to Canadians
Greenphire and Exostar Partner to Deliver Seamless, Secure Access to Clinical Research Site Payment Solution
PleurX™ Catheter System Receives FDA 510(k) Clearance for Specific Non-Malignant Recurrent Pleural Effusions
First Pulmonary Embolism Patients in Hong Kong Treated with the EKOS® System
Ipsen to Acquire Oncology Assets from Merrimack Pharmaceuticals

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  BizJobs.com

Visit  Al Rowaad Advocates & Legal Consultants





 
  ©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)