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Tuesday, September 14, 2004

The CDER Handbook was developed to provide a user-friendly resource on the World Wide Web for obtaining information on the Center's processes and activities of interest to regulated industry, health professionals, academia, and the general public. The CDER Handbook is arranged according to the four major activities that the Center is involved in: New Drug Development and Review, Generic Drug Review, Over-the-Counter Drug Review, and Post Drug Approval Activities. Two other categories, "Communicating with CDER" and "Other Topics" are included to describe the additional activities and topics of interest at the Center. Each selection in the CDER Handbook contains a concise description of a particular process or activity and often provides resources or links to other sites for further information on a given subject. In addition, the CDER Handbook provides an "Acronym List" to provide you with definitions of unfamiliar acronyms used in CDER. There is also a "People in CDER" section which provides links to information on how CDER is organized as well as to key points of contact within the Center. Some documents in the CDER Handbook are in Portable Document Format (PDF) to retain the original format. These documents are identified in the Handbook with the PDF symbol. To view or print these documents, you must use the Adobe Acrobat Reader. The Acrobat Reader is free and available directly from Adobe's website with full installation instructions. To download Acrobat Reader, click on the icon below. Click Here	New and Hot Few Enroll in Low-Cost Drug Demonstration WASHINGTON, Sept. 10 - A new program to provide low-cost drugs to people with cancer and other serious illnesses has fallen far short of expectations, as just a small number of eligible patients have applied for the benefits, officials said Friday. The Bush administration was planning a nationwide lottery to choose 50,000 Medicare beneficiaries from 500,000 potentially eligible for the program, a precursor to Medicare drug benefits that will start in 2006. Fewer than 7,000 people have applied, and fewer than 4,000 are enrolled, the administration said. The deadline for applications is Sept. 30. No one is sure why the response has been so slow. Full story from NY Times HERE One reason the response has been so slow is that information on the new program is very difficult to find. The program is called The Medicare Replacement Drug Demonstration. There are still many enrollment slots available! It is not too late to request or submit an application. Find out about the program HERE.
	Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors The editors of 11 top medical journals including the prestigious New England Journal of Medicine have turned the academic publishing and clinical trials worlds upside down when they announced earlier this week that they would stop publishing results of drug trials that aren't registered in a central database. Read the Q&A with Dr. Jeffrey M. Drazen (editor of NEJM) on reasons why the action was taken and the likely changes to come. More>>> Industry to publish drug data: Here is a follow up story to the one above from the LA Times. Pharmaceutical Research and Manufacturers of America, a trade association representing most drug companies, announced Tuesday that as of Oct. 1, it would have a Web site - www.clinicalstudyresults.org - with access to all study results since October 2002 for drugs marketed in the United States. Pharmaceutical company officials admitted Thursday that the public's confidence has been eroded by the controversy over the firms' failure to publish unfavorable results from clinical trials of the safety and effectiveness of antidepressants for children. "We believe there is clearly a societal crisis in terms of credibility for drug companies," Dr. John R. Hayes of Eli Lilly & Co. told the House Energy and Commerce Committee.
Veritas Research's (N. Massapequa, NY) trial monitors had a problem most every other CRA will find familiar. After lugging a laptop, PDA, cell phone, and pager around from site to site, they were still using a pencil on the back of an envelope to confirm CRF entries. What the company needed, and what it designed, was a preprogrammed set of algorithms to plug trial data into. The result saves not only scrap paper but precious time. CRAtoolbox™ comes complete with over a dozen common clinical calculations, including converting height from yards to meters, weight from pounds to kilos, temperature from Celsius to Fahrenheit, and the bête noir of clinical trials, the clock time to military time. It also provides body mass index, pregnancy dates, dosage data, and more. These are all common, well-known calculations, and odds are one or two geniuses out there can do it all in their heads perfectly. For the rest of us, though, CRAtoolbox provides the quick, error-free work that gives the appearance that we're geniuses. CRAtoolbox is available for immediate download for most Palms and Pocket PCs. At $50 a pop, it may pay for itself in time saved in the first monitoring visit. Link Here is an even better solution to the problem...For Free: Data Tools has a Measurement Unit Converter for your desktop with over 58,000 individual unit conversions immediately available. An intuitive, easy-to-use unit-conversion program that converts many units including; volume, distance, temperature, acceleration, time, speed, mass, power, torque, density, pressure, energy, and many others. In addition to the best Measurement Converter available they also offer a free download from the same page a desktop Materials Compatability- Over 14,000 combinations of gases and liquids are displayed with their affect on various materials and a Technical Glossary - Thousands of technical terms at your fingertips. Don't go on another site visit without it. Download here. View and use the on-line Measurement Unit Conversion here (no download required), the On-Line Technical Glossary Here and the On-Line
	The centerpiece of the Career Innovations suite of recruitment services is HireHealth.com - The BioPharmaceutical Career Site. Boasting a nationwide membership base of over 500,000 job seekers, HireHealth.com is the premier online resource for positions spanning the entire drug discovery continuum - from the laboratory to the executive suite. An integral part of the success of HireHealth.com lies in our Career Expos, live regional recruiting events featuring up to 40 leading biopharmaceutical employers. Through extensive candidate sourcing and screening, we are able to provide our corporate partners outstanding ROI - with each participating company averaging between three and five hires per event. Our Career Receptions are held in such industry enclaves as New York City, Princeton NJ, Cambridge MA, King of Prussia PA, Research Triangle Park, San Francisco and San Diego.

Wednesday, April 07, 2004

The CDER Handbook was developed to provide a user-friendly resource on the World Wide Web for obtaining information on the Center's processes and activities of interest to regulated industry, health professionals, academia, and the general public. The CDER Handbook is arranged according to the four major activities that the Center is involved in: New Drug Development and Review, Generic Drug Review, Over-the-Counter Drug Review, and Post Drug Approval Activities. Two other categories, "Communicating with CDER" and "Other Topics" are included to describe the additional activities and topics of interest at the Center. Each selection in the CDER Handbook contains a concise description of a particular process or activity and often provides resources or links to other sites for further information on a given subject. In addition, the CDER Handbook provides an "Acronym List" to provide you with definitions of unfamiliar acronyms used in CDER. There is also a "People in CDER" section which provides links to information on how CDER is organized as well as to key points of contact within the Center. Some documents in the CDER Handbook are in Portable Document Format (PDF) to retain the original format. These documents are identified in the Handbook with the PDF symbol. To view or print these documents, you must use the Adobe Acrobat Reader. The Acrobat Reader is free and available directly from Adobe's website with full installation instructions. To download Acrobat Reader, click on the icon below. Click Here	New and Hot Few Enroll in Low-Cost Drug Demonstration WASHINGTON, Sept. 10 - A new program to provide low-cost drugs to people with cancer and other serious illnesses has fallen far short of expectations, as just a small number of eligible patients have applied for the benefits, officials said Friday. The Bush administration was planning a nationwide lottery to choose 50,000 Medicare beneficiaries from 500,000 potentially eligible for the program, a precursor to Medicare drug benefits that will start in 2006. Fewer than 7,000 people have applied, and fewer than 4,000 are enrolled, the administration said. The deadline for applications is Sept. 30. No one is sure why the response has been so slow. Full story from NY Times HERE One reason the response has been so slow is that information on the new program is very difficult to find. The program is called The Medicare Replacement Drug Demonstration. There are still many enrollment slots available! It is not too late to request or submit an application. Find out about the program HERE.
	Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors The editors of 11 top medical journals including the prestigious New England Journal of Medicine have turned the academic publishing and clinical trials worlds upside down when they announced earlier this week that they would stop publishing results of drug trials that aren't registered in a central database. Read the Q&A with Dr. Jeffrey M. Drazen (editor of NEJM) on reasons why the action was taken and the likely changes to come. More>>> Industry to publish drug data: Here is a follow up story to the one above from the LA Times. Pharmaceutical Research and Manufacturers of America, a trade association representing most drug companies, announced Tuesday that as of Oct. 1, it would have a Web site - www.clinicalstudyresults.org - with access to all study results since October 2002 for drugs marketed in the United States. Pharmaceutical company officials admitted Thursday that the public's confidence has been eroded by the controversy over the firms' failure to publish unfavorable results from clinical trials of the safety and effectiveness of antidepressants for children. "We believe there is clearly a societal crisis in terms of credibility for drug companies," Dr. John R. Hayes of Eli Lilly & Co. told the House Energy and Commerce Committee.
Veritas Research's (N. Massapequa, NY) trial monitors had a problem most every other CRA will find familiar. After lugging a laptop, PDA, cell phone, and pager around from site to site, they were still using a pencil on the back of an envelope to confirm CRF entries. What the company needed, and what it designed, was a preprogrammed set of algorithms to plug trial data into. The result saves not only scrap paper but precious time. CRAtoolbox™ comes complete with over a dozen common clinical calculations, including converting height from yards to meters, weight from pounds to kilos, temperature from Celsius to Fahrenheit, and the bête noir of clinical trials, the clock time to military time. It also provides body mass index, pregnancy dates, dosage data, and more. These are all common, well-known calculations, and odds are one or two geniuses out there can do it all in their heads perfectly. For the rest of us, though, CRAtoolbox provides the quick, error-free work that gives the appearance that we're geniuses. CRAtoolbox is available for immediate download for most Palms and Pocket PCs. At $50 a pop, it may pay for itself in time saved in the first monitoring visit. Link Here is an even better solution to the problem...For Free: Data Tools has a Measurement Unit Converter for your desktop with over 58,000 individual unit conversions immediately available. An intuitive, easy-to-use unit-conversion program that converts many units including; volume, distance, temperature, acceleration, time, speed, mass, power, torque, density, pressure, energy, and many others. In addition to the best Measurement Converter available they also offer a free download from the same page a desktop Materials Compatability- Over 14,000 combinations of gases and liquids are displayed with their affect on various materials and a Technical Glossary - Thousands of technical terms at your fingertips. Don't go on another site visit without it. Download here. View and use the on-line Measurement Unit Conversion here (no download required), the On-Line Technical Glossary Here and the On-Line
	The centerpiece of the Career Innovations suite of recruitment services is HireHealth.com - The BioPharmaceutical Career Site. Boasting a nationwide membership base of over 500,000 job seekers, HireHealth.com is the premier online resource for positions spanning the entire drug discovery continuum - from the laboratory to the executive suite. An integral part of the success of HireHealth.com lies in our Career Expos, live regional recruiting events featuring up to 40 leading biopharmaceutical employers. Through extensive candidate sourcing and screening, we are able to provide our corporate partners outstanding ROI - with each participating company averaging between three and five hires per event. Our Career Receptions are held in such industry enclaves as New York City, Princeton NJ, Cambridge MA, King of Prussia PA, Research Triangle Park, San Francisco and San Diego.

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