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FDAs in Medical News

CT radiation dose report released by American Association of Physicists in Medicine

...e not regulatory bodies, the AAPM and allied organizations like the American College of Radiology (ACR) play important roles in helping to achieve the fdas goal of keeping the radiation dose as low as reasonably achievable, consistent with the medical need, by making recommendations and providing accredit...

American Chemical Society's Weekly PressPac -- Jan. 30, 2008

...other researchers. To assess the adequacy of iodine nutrition, the researchers tested 88 samples of iodized salt and found that 47 did not meet the fdas recommended level. In addition, amount of iodine varied in individual packages and brands of salt. The researchers expressed particular concern about ...

Medifast Offers 5 Heart Healthy Tips in Recognition of Friday's National Wear Red Day

...2-5 pounds per week. Among its meal replacement options Medifast offers 33 choices that contain high amounts of soy, to meet the requirement for the fdas Heart Healthy Claim. The claim arose from 27 studies demonstrating soy protein's utility in lowering levels of total cholesterol and low-density LDL. ...

National study will look at German-made heart pump for children needing heart transplants

...t importance to us. Between 2000 and 2007, prior to FDA approval to begin the study, pediatric hospitals in the U. S. used the Berlin Heart under the fdas emergency or compassionate use regulations. Each time a physician wanted to implant the Berlin Heart in a child dying of heart failure, a special appe...

BDSI files FDA NDA for BEMA Fentanyl

...tanyl has minimum peak sales projections of $250 million in the U.S. according to BDSI projections. Our team has been very diligent in following the fdas guidance on the development of BEMA Fentanyl and the preparation of the NDA, said Dr. David Wright, Director of Regulatory Affairs at BDSI. Given the ...

Newer antidepressants led to less, not more, teen suicides

...who are adversely affected by taking these antidepressants, it has to be a very small group. The findings are compelling, especially in view of the fdas requirement in May for major black-box warnings to be placed on antidepressants for youth and young adults that advise of a potential suicide risk. Th...

Depression Therapy Reduces Suicide Attempts

..., even teens and young adults, suicide attempts tend to be rarer right after starting antidepressant medication than beforehand. He echoed the fdas recommendations that doctors regularly monitor their patients during treatment with antidepressants to ensure that they are receiving the right medica...

FDA: New Drug for Advance Kidney Cancer

... and cell survival. 'We have made significant advances in the battle against kidney cancer,' said Steven Galson, M.D., M.P.H., director of the fdas Center for Drug Evaluation and Research. 'Torisel is the third drug approved for this indication in the past 18 months, and one that shows an increase...

Body Parts Industry Of U.S Under Investigation

...tially the business of harvesting organ and non-organ parts for transplant, has now more than 2000 companies dealing within it. This Tuesday, the fdas tissues chief, Dr. Celia Witten, pronounced the industry safe and claimed the government oversight was working for the more than 1 million medical pro...

A New Product Offering protection against anthrax

...ing questions to the products' developer, who said he was unaware that Bio-Germ was being sold, as the products are still being tested. If in the fdas view Bio-Germ is deemed to be violating the law, it could stop the company selling the products, or refer the matter to federal prosecutors. The Feder...
FDAs in Biological News

U of I researcher develops power-packed soy breakfast cereal

...ms of it soy protein) and 5 grams of fiber into one serving of a cereal that people find appealing. In doing so, she also met the requirements for the fdas soy, high protein, and fiber health claims. Other products have used soy as a fortifying ingredient rather than a major base ingredient, she said. ...

Stanford researchers publish review of US medical device regulation

...n be improved for manufacturers, and more importantly, for patients. The fdas Center for Devices and Radiological Health (CDRH) is currently taking steps...party inspections; communicating risk/benefit information; and refining the fdas communications strategy. Distinction from Drug Regulation In contra...

American Chemical Society's weekly PressPac -- Jan. 2, 2008

...benzene found did not pose a safety concern for consumers. In the study, fdas Patricia Nyman and colleagues point out that benzene can form at ppb levels...ng benzene formation. The report also describes the in-house validation of fdas analytical method for determining benzene in beverages. JS ARTICLE #2 F...

Sequella receives US and EU orphan drug status for SQ109 for the treatment of TB

... need to readdress the treatment of this infectious and deadly disease. To accelerate our clinical programs, we will continue to work closely with the fdas Office of Orphan Products Development and the EMEAs Committee for Orphan Medicinal Products as we move through the clinical and regulatory process. ...

UNC study questions FDA genetic-screening guidelines for cancer drug

...T1A1, known as UGT1A1*28. At lower doses, however, the risk was the same regardless of what UGT1A1 gene the patients had. Many institutions saw the fdas recommendation as a mandate to test all patients before treating them with irinotecan even though many clinicians didnt think it was always necessary ...
FDAs in Biological Technology

Support Regulatory Change to Boost Wisconsins Biotech Sector

...atory change is in the air. Wisconsin biotech companies should monitor the fdas actions closely over the coming months. Several dominant players in the in...meeting with industry representatives, Steven Gutman, M.D. (director of the fdas Office of In Vitro Diagnostics) indicated that the Agency is revisiting t...

Fast Track: Topics for Consideration

... lead to premarket review of the products by the agency. Another example is fdas proposed registration requirements for food facilities and for prior notice...rable resources at FDA and these demands are likely to grow. One example is fdas role in patent term extension. Another is the agencys effort to control pre...

Fast Track: FDA User Fees: Do Faster Review Times Justify the Financial Burden?

...e additional reviewers in order to accelerate application reviews. However, fdas review of applications is only a small component in the lengthy product app...ch other inefficiency within the agency. Recently, the directors of each of fdas Centers lamented that the Agencys information management is woefully inadeq...

The Coming of Biotech Generic Pharmaceuticals

... a number of cancer drugs in recent years have been approved off phase II data without the need for doing or completing phase III trials. 3) The fdas orphan drug designation also plays well in oncology as most cancers have a disease prevalence under 200,000 patients (except breast, prostate and lung...

Midwest Investment Bank Piper Jaffray Resurges in New York City

...e including Barbeau Pharma, which, by full disclosure, employs me. Company founder and chief scientific officer Don Barbeau led a panel session on the fdas 505(b)(2) regulatory pathway. If youre wondering about that FDA mumbo jumbo, suffice it to say that the normal pathway of registering or getting a...

Midwest large-cap life-science sector is solid in first quarter

... results dont include further bad news for the pharmaceutical sector. You may have noticed headlines at the end of last week when Pfizer announced the fdas decision to pull its Cox-2 inhibitor (Bextra) off the market. This stronger-than-expected action by the FDA went in the face of its own advisory co...

Challenging times for FDA and drug companies equals IT opportunities

...pipeline problem, along with heightened attention to drug safety issues and fdas initiatives for bar codes and radio-frequency identification technology on ...ons of patients will not be identified until after a drug is widely used. fdas adverse event reporting system is dependent on voluntary reports from healt...

FDA programs encourage and expedite drug development and approval

...and that a particular program is appropriate for the product and the companys overall strategy. Orphan Product Requirements and Incentives The fdas Office of Orphan Products Development makes decisions on applications requesting orphan product designation. The threshold standard is that the pro...
FDAs in Biological Products

Agilent MSD Security ChemStation for GC and GC/MS from Agilent Technologies

Description:...data processing, quantification, library searching and reporting, addressing all the aspects of data security, integrity, and traceability mandated by fdas 21 CFR Part 11....
Company:Agilent Technologies
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