FDA Pharmaceutical and Medical Device Books
Five-Volume Title 21 CFR Drugs/Biologics Set
Published: April 2009 |
Price:
$300
Order your Five-Volume Title 21 CFR Drugs/Biologics Set today and receive each volume within days of its release! Why wait? Be the first to receive the new five-volume 2009 official FDA Code of Federal Regulations (CFR) for drug and biologic manufacturers! The federal government has compiled the new Title 21 CFR with all the FDA rules for drugs and biologics revised through April 1, 2009.
Nine-Volume Title 21 CFR Set
Published: April 2009 |
Price:
$585
Order your complete Nine-Volume Title 21 CFR Set today and receive each volume within days of its release! The federal government has just compiled the new complete Nine-Volume Title 21 CFR Set for 2009 with all of the FDA rules for drugs, devices and biologics revised through April 1, 2009.
Two-Volume Title 21 CFR Devices/Diagnostics Set
Published: April 2009 |
Price:
$160
Be the first to receive the new 2009 official FDA Code of Federal Regulations (CFR) for device and diagnostics manufacturers. The federal government has compiled the new two-volume Title 21 CFR with all the FDA rules revised through April 1, 2009, and you can receive your copies as soon as they’re released. Why wait? Reserve your 2009 Two-Volume Title 21 CFR Devices/Diagnostics Set now for priority shipping immediately as each volume is released over the coming months.
A Sponsor's Guide to Auditing IRBs: Detecting Deficiencies and Ensuring Best Practices
Published: June 2009 |
Pages: 35 |
Price:
$357
A Sponsor’s Guide to Auditing IRBs: Detecting Deficiencies and Ensuring Best Practices is the one step-by-step management report that gives you the tools you need to determine if your IRBs are complying with federal regulations. With Congress threatening legislation that will fortify FDA and HHS oversight, you’ll need to act fast. Order your copy now to discover how to avoid an IRB compliance disaster once and for all.
Adverse Event Compliance in Device and Diagnostics Clinical Trials
Published: December 2007 |
Pages: 29 |
Price:
$337
| ISBN: 978-1-60004-156-3
From FDAnews — Adverse Event Compliance in Device and Diagnostics Clinical Trials. Find clear, concise guidelines on adverse event reporting — specifically for device and diagnostics trials. Make sense of all the whats, whens and hows surrounding adverse event reporting. Once an adverse event happens, it’s too late: you have just 10 working days to submit to the IRB and 10 days after that to get results to the FDA. Stay in control, even when unanticipated events happen.
Adverse Event Compliance in Drug and Biologic Clinical Trials
Published: September 2007 |
Pages: 31 |
Price:
$337
| ISBN: 978-1-60004-156-3
Adverse Event Compliance in Drug and Biologic Clinical Trials, the management report from FDAnews gives dependable guidance on adverse event reporting specifically for drug and biologic companies. Make sense of the key rules and requirements of the FDA and the OHRP and find out what the FDA considers a reportable effect.
Authorized Generics: What's Really Going On?
Published: May 2007 |
Pages: 175 |
Price:
$337
| ISBN: 0-9774003-6-8
For the first time, here's an impartial look at where authorized generics stand in Congress, court, authorized generics and the market — and how competitive responses from brand and generic firms will determine who ultimately stands in the winner's circle.
Biologic-Device Combination Products: A Guide to Regulatory Review and Approval
Published: September 2008 |
Pages: 37 |
Price:
$397
| ISBN: 978-1-60004-011-5
Published by FDAnews, this management report will help you gain a thorough understanding of the challenges you’re facing and the best way to manage your development process.
Blood Cancer Drug Discoveries: What the Future Holds
Published: April 2008 |
Pages: 245 |
Price:
$2,655
Published by Espicom — Blood Cancer Drug Discoveries: What the Future Holds, the strategic report provides a comprehensive review of current and future treatments for such major blood cancer therapy areas as chronic lymphocytic leukemia, chronic myeloid leukemia, acute myeloid leukemia, and multiple myeloma and non-Hodgkin's lymphoma.
British Pharmacopoeia 2009
Published: August 2008 |
Pages: 3500 |
Price:
$1,595
| ISBN: 9780113227990
British Pharmacopoeia 2009 is the essential reference that plays a vital role in ensuring that all medicinal substances sold in the UK market continue to meet stringent standards of safety, quality and efficacy. It comprises a series of monographs, each detailing mandatory standards for active substances, excipients and formulated preparation, together with supporting General Notices, Appendices (test methods, reagents, etc.) and Reference Spectra.
Cancer Vaccines: Market Forecasts, New Developments and Pipeline Analysis
Published: November 2008 |
Pages: 250 |
Price:
$4,395
Published by Kalorama Information — Cancer Vaccines: Market Forecasts, New Developments and Pipeline Analysis is your best resource to get a thorough overview of emerging treatments in this area — including a realistic estimate of the cancer vaccine market for the near term for 11 different types of cancer — and profiles of 13 leading developers.
Change Control: Best Practices for FDA-Compliant Drug and Biologic Manufacturers
Published: February 2007 |
Pages: 143 |
Price:
$335
| ISBN: 1-60004-136-1
Glean real-world insight with examples of working change control systems, specifically targeted to the unique needs of drug and biologic manufacturers, with this new management report. Don't delay, order this distinctive management report filled with common sense procedures on change control that you can use today.
Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers
Published: March 2007 |
Pages: 112 |
Price:
$335
| ISBN: 1-60004-138-8
Don't miss out! Successfully sidestep the delayed approvals, lost product batches and plummeting profits that can result from change control failures with this comprehensive report. Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers.
China Pharmaceutical Market Report 2009
Published: February 2009 |
Pages: 34 |
Price:
$500
China Pharmaceutical Market Report 2009, the research report that contains key information on important aspects of the Chinese pharmaceutical market. This book provides an overview of current conditions in the Chinese healthcare market. It is an invaluable resource, whether you are planning to expand your reach into China for the first time or simply need a veteran’s perspective on the country’s marketplace to manage your ongoing efforts.
China Pharmaceutical Regulatory Report 2009
Published: April 2008 |
Pages: 56 |
Price:
$1,500
China Pharmaceutical Regulatory Report 2009, the research report that gives you a thorough understanding of the Chinese regulatory structure governing the drug industry. You’ll get a complete discussion of the laws and regulations that govern the testing, registration, manufacturing, importing, marketing and sales of pharmaceutical products. All this and more from Ames Gross and John Minot of Pacific Bridge Medical, the consulting firm that has provided more than 200 companies with regulatory information and business strategies to develop Asian markets.
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