Navigation Links
New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products
Date:7/13/2010

AGAWAM, Mass., July 13 /PRNewswire/ -- A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/)

Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, "Combination Products 2.0: Applying the New FDA Regulations," Stev
'/>"/>

SOURCE Microtest
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes
2. Make Meth Ingredients Prescription-Only Says Former White House Drug Spokesman Bob Weiner; Oregon Did and Cut Crisis by Half
3. Abbott Chairman and CEO Miles D. White to Present at Sanford Bernstein Strategic Decisions Conference
4. Dr. Robert B. Arnot Releases White Paper on the Silent Threat of H1N1 and Other Infectious Diseases
5. New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers
6. Whitepaper From Mirial Explains how Visual Communication Technology can Improve Healthcare Services
7. BIA Publishes White Paper: ISO 9000 Role in Document Review, Emphasizes Quality Equals Defensibility
8. Society of Gynecologic Oncologists Issues White Paper on HPV Vaccines Impact on Cervical Cancer Prevention
9. ALP Life Sciences, LLC Announces Nanoveson(TM) Patent Filing and Whitepaper Availability on Proposed Therapy for Non-Alcoholic Fatty Liver Disease (NAFLD) and Comorbid Diseases
10. White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
11. White Nose Syndrome: Is Pennsylvania Next?
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... -- Ortho Clinical Diagnostics (OCD) today announced that ... and Communications Officer, effective immediately. As the newest member ... the company,s worldwide corporate brand and communication strategies as ... company by adding sites in countries outside the U.S. ... Dr. Martin Madaus . Since becoming ...
(Date:8/3/2015)... Global physiotherapy equipments ... 24.7 billion by 2022, according to a new ... of neurological and musculoskeletal disorders are expected to ... period. The presence of efficient and effective therapies ... technologies coupled with implementation of favorable government policies ...
(Date:8/3/2015)... ANGELES, Aug. 3, 2015  CytRx Corporation (NASDAQ: ... in oncology, today reported financial results for the three ... overview of recent accomplishments and upcoming milestones for its ... 2015 has been very productive for CytRx. Enrollment in ... aldoxorubicin in soft tissue sarcoma (STS) continues on track ...
Breaking Medicine Technology:Ortho Clinical Diagnostics Appoints Kristie Bouryal Chief Corporate Brand and Communications Officer 2Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 2Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 3Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 4Physiotherapy Equipments Market Worth $24.7 Billion By 2022: Grand View Research, Inc. 5CytRx Reports 2015 Second Quarter Financial Results 2CytRx Reports 2015 Second Quarter Financial Results 3CytRx Reports 2015 Second Quarter Financial Results 4CytRx Reports 2015 Second Quarter Financial Results 5CytRx Reports 2015 Second Quarter Financial Results 6CytRx Reports 2015 Second Quarter Financial Results 7CytRx Reports 2015 Second Quarter Financial Results 8CytRx Reports 2015 Second Quarter Financial Results 9CytRx Reports 2015 Second Quarter Financial Results 10CytRx Reports 2015 Second Quarter Financial Results 11CytRx Reports 2015 Second Quarter Financial Results 12CytRx Reports 2015 Second Quarter Financial Results 13CytRx Reports 2015 Second Quarter Financial Results 14
... Dec. 4 Long-term data published in,EuroIntervention showed ... (MVA),after repair with the MitraClip(R) system to correct ... mitral stenosis. Additionally,with two years of follow-up, none ... surgery for mitral stenosis. At 12 months no,important ...
... newly diagnosed patients with a life-threatening type of leukemia to be ... , - Exjade results at ASH to show benefits ... damage key organs , , - ... to report on optimal post-surgery treatment strategy, Femara vs. tamoxifen , ...
Cached Medicine Technology:Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System 2Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System 3Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System 4More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 2More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 3More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 4More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 5More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 6More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 7More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 8More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 9More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 10More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 11More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 12More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 13More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 14More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 15More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 16More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 17More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 18More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 19More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 20More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 21More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 22
(Date:8/3/2015)... Irvine, CA (PRWEB) , ... August 03, 2015 ... ... for Hispanic Health notes that while an overwhelming number of Hispanics believe ... health. , The overwhelming 70 percent of participants queried said making diet changes ...
(Date:8/3/2015)... , ... August 03, 2015 , ... ... of its industry-defining contract lifecycle management solution, as well as announced the date ... increase the speed and ease of contract management tasks as well as enhancements ...
(Date:8/3/2015)... OR (PRWEB) , ... August 03, 2015 , ... ... California’s Modoc National Forest, to Ahjumawi Lava Springs, California’s northernmost and among its ... California’s largest untapped ground water aquifers, whose main outflow is at Ahjumawi Lava ...
(Date:8/3/2015)... ... August 03, 2015 , ... Illinois Health & Science ... 31. , The acquisition includes all of IBAM NA’s cyclotron sites and research ... both, a robust regionally located business, as well as a large manufacturing hub in ...
(Date:8/3/2015)... ... , ... Foot and Ankle Specialists of the Mid-Atlantic (FASMA) is ... practice in the Mid-Atlantic region – and the second largest in the United States ... , Dr. Hetal Kathrotiya-Mago is a Maryland native. She grew up in Laurel, Maryland. ...
Breaking Medicine News(10 mins):Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 2Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 3Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 4Health News:Novatus Unveils Milestone Software Release 2Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 2Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 3Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 4Health News:Illinois Health & Science Expands Nuclear Medicine Footprint With Purchase of IBA Molecular North America, Inc. 2Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 2Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 3Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 4
... less likely, women more, to develop the disorder, study finds, ... a neurological disorder characterized by a strong urge to move ... than others, a new U.S. study has found. , Researchers ... About 12 percent of those who were black, compared with ...
... National Laboratory are collaborating on a study to determine ... the space shuttle can be used to predict tissue ... therapy. The study is examining the utility of ... from the study are being displayed during the American ...
... currently under development by the University of Pittsburgh School ... after radiation exposure, according to a study by Pitt ... p.m. today during the American Society for Radiation Oncology ... is a free-radical scavenger targeted to the mitochondria, the ...
... in packaging, paper and exposures were evident in most ... -- Chemicals used in food packaging, paper and textile ... researchers have found. , Previous studies have found that ... most people. In this new study, a team at ...
... Skin Cell is the Star Avatar at KidsSkinHealth.org , SCHAUMBURG, ... by dermatologists lets kids learn how to practice ... , greasy hair, a poison ivy rash ... Cell,s Life," is just one of the many features on the American ...
... 2 Blue Cross Blue Shield of Michigan and ... innovative oncology treatment initiative aimed at enhancing the quality ... , OPR, a statewide physician organization comprised ... working with oncology leaders from across Michigan, as well ...
Cached Medicine News:Health News:Restless Legs May Vary by Race and Gender 2Health News:Adapting space-industry technology to treat breast cancer 2Health News:Adapting space-industry technology to treat breast cancer 3Health News:Household Chemicals May Affect Cholesterol Levels 2Health News:Dermatologists Launch New Web Site and Game to Teach Kids about Healthy Skin, Hair and Nail Habits 2Health News:Dermatologists Launch New Web Site and Game to Teach Kids about Healthy Skin, Hair and Nail Habits 3Health News:Blue Cross Blue Shield of Michigan and Michigan Oncologists Launch Statewide Initiative to Create Cancer Guidelines 2Health News:Blue Cross Blue Shield of Michigan and Michigan Oncologists Launch Statewide Initiative to Create Cancer Guidelines 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: