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- Joint NCI-FDA Fellowship Program Announced
- In preparation for the new generation of molecular-based oncology medical products, the National Cancer Institute NCI, part of the National Institutes of Health, and the Food and Drug Administration FDA announced on February 16 the creation of an NCI-In preparation for the new generation of molecular-based oncology medical products, the...
- Research articles 2005-04-01
- Viewpoint: Sound science blind to opposing views.(musings about the safety of phthalates and PVC medical products)(Brief Article)(Critical Essay)
- It feels strange to be sitting in my office, just a few miles from the Pentagon and three blocks from the White House, writing this column about phthalates and PVC medical products. It seems trivial, as thoughts and prayers gravitate toward concern a It feels strange...
- Research articles 2001-09-24
- FDA Warns on Risks of PVC Medical Products.(unsafe amounts of di-2-ethylhexylphthalate)(Brief Article)
- THE FOOD & DRUG Administration FDA warned last week that some medical products made from polyvinyl chloride PVC could expose patients to unsafe amounts of di-2-ethylhexylphthalate DEHP, but the agency said it has not seen any evidence of THE FOOD & DRUG Administration...
- Research articles 2001-09-10
- Myths and realities in medical packaging: this round-up of packaging myths provides a reality check on the real world of packaging medical products. Table I shows medical device FDA-assisted recalls due to packaging failures. (design).
- Myth: We will select the package just before we introduce the product. It will be fine. Reality: The package is an integral part of the product, especially for products that will be sterilised. The package protects and cushions the product, c...
- Research articles 2003-03-01
- Shares of Phoenix-Based Medical Products Firm Skid on FDA Panel's Vote.
- Knight Ridder/Tribune Business News Knight Ridder/Tribune Business News
- Research articles 1999-01-15
- Hot Selling FDA Regulatory Guidance Manual Released: ``Medical Software Validation-2000''
- Health/Medical Writers COSTA MESA, Calif.--BW HealthWire--April 12, 2000--Sales are climbing rapidly for the hot new "Medical Software Validation Guidance Manual-2000" the publisher announced today. It's available only from Biomedical Market NewsletterR -- not the FDA or bookstores. These are important documents...
- Research articles 2000-04-12
- Activists Target Vinyl Medical Products.
- Industry counters that attacks on plasticizers are exaggerated and misleading. ENVIRONMENTAL ACTIVISTS are expanding their campaign against the use of phthalate plasticizers by targeting vinyl medical products that can leach a suspected cance Industry counters that attacks on...
- Research articles 1999-03-01
- Boulder, Colo., Medical Products Firm Says FDA Warning Hampered Performance.
- By Matt Branaugh, Daily Camera, Boulder, Colo. Knight Ridder/Tribune Business News By Matt Branaugh, Daily Camera, Boulder, Colo. Knight Ridder/Tribune Business News
- Research articles 2001-05-09
- Challenge and Opportunity on the Critical Path to New Medical Products
- Today's revolution in biomedical science has raised new hope for the prevention, treatment, and cure of serious illnesses. However, there is growing concern that many of the new basic science discoveries made in recent years may not quickly yield more effective, more affordable and safe medical products for patients. This...
- White papers 2004-03-01
Additional Resources
- FDA, Defense Department Share Data to Enhance Medical Product Safety Reviews.
- M2 PRESSWIRE-3 August 2007-US FDA: FDA, Defense Department Share Data to Enhance Medical Product Safety ReviewsC1994-2007 M2 COMMUNICATIONS LTD RDATE:02082007 Data from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety...
- Research articles 2007-08-03
- Physician Suits Against Pharmaceutical And Medical Device Manufacturers: Friend Turned Foe?
- This paper discusses that pharmaceutical and medical device manufacturers are all too familiar with the regulatory risks and with the potential for product liability claims from patients whenever a product is manufactured and sold. The Food and Drug Administration FDA has sweeping powers to regulate manufacturers before and after a...
- White papers 2003-01-01
- INC Research Launches Pediatric and Adolescent Product Services Group
- Business Editors & Health/Medical Writers RALEIGH, N.C.--BW HealthWire--March 13, 2001 INC Research today announced the formation of its Pediatric and Adolescent Product Services Group dedicated to providing clinical development services for central nervous system drugs used in neonatal, pediatric and adolescent care. The group was formed to...
- Research articles 2001-03-13
- Advanced Medical Optics, Inc. Q3 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator : [Operator Instructions]. And your first audio question comes from the line of Chris Cooley with FTN Midwest Securities. Chris Cooley - FTN Midwest Research Thanks. Good morning. Can you heart me okay? James V. Mazzo - Chairman of the Board, President and...
- Earnings calls 2007-10-25
- U.S. FDA tackles gray area of social media
- By Deepa Seetharaman WASHINGTON (Reuters)- Drug makers, Internet companies and nonprofits packed a hearing into what is a gray area for U.S. health regulators: how far Twitter, Wikipedia, blogs and other social media can go in promoting drugs. The two-day public hearing, convened Thursday by the Food and Drug Administration,...
- News items 2009-11-12
- FDA, Clinical Trial Calendar Updates: Thoratec, Allos Therapeutics
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision...
- External links 2009-04-21
- FDA, Clinical Trial Calendar Updates: Discovery, Impax Labs
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision...
- External links 2009-04-21
- FDA Calendar Updates: CombinatoRx, Covidien
- Mike Havrilla submits: Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the...
- External links 2009-07-05
- FDA Allows U.S. Doctors to Continue Use of FBI-Identified 'Terrorist Tool' in Treatment of Children, Finds SafeMinds
- "If the FBI considers a small amount of mercury in the hands of a terrorist to be a chemical weapon, then the FDA Food and Drug Administration should realize that a medical product containing a concentrated amount of mercury in the hands of a pedia"If the FBI considers a small...
- Research articles 2004-03-11
- Device allowing bloodless surgery approved by FDA.(MPMD)
- Rita Medical Systems Inc., Fremont, Calif., announces that the Habib 4X Resection device has received clearance from the U.S. Food and Drug Administration FDA and that the company will begin U.S. commercialization of the product for use in vascular Rita Medical Systems Inc., Fremont, Calif., announces...
- Research articles 2006-01-01
- Lifecore Receives FDA Center Director's Determination to Approve GYNECARE INTERGEL Adhesion Prevention Solution PMA
- Business Editors & Health/Medical Writers CHASKA, Minn.--BUSINESS WIRE--Oct. 5, 2001 LIFECORE BIOMEDICAL, INC. (Nasdaq:LCBM) announced today that it has received notice that Dr. David W. Feigal, Director, FDA's Center for Devices and Radiological Health, has concurred with the unanimous recommendation for approval of Lifecore's adhesion prevention product PMA...
- Research articles 2001-10-05
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