FDA Pharmaceutical and Medical Device Books
Published: March 2012 | Price: $199
When it comes to valuing a company’s assets, bricks and mortar are the least of it. For most life sciences companies, the core value of a company’s assets lies in intellectual property — patents, copyrights, trademarks, secret processes.
Published: March 2012 | Price: $1,390
You know there’s money to be made in the global generic drug market. But which countries are up, which are down and which are coming into their own? Which companies are working together, who’s suing whom and how could developments inside top industry players affect expansion for makers of generics and biologics? Here are the answers you need today to identify the best —and safest — business prospects for the years ahead. Order today.
Published: February 2012 | Pages: 223 | Price: $377 | ISBN: 978-1-60428-020-3
In this new resource from FDAnews, you’ll find what you must know to create a clinical data management plan that combines trouble-shooting best practices with insider intelligence of exactly what you’re likely to encounter during an FDA inspection.
Published: February 2012 | Pages: 214 | Price: $377 | ISBN: 978-1-60428-018-0
Before you begin to modify an existing trial, this new report from FDAnews maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA’s preferences, this one report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis.
Published: February 2012 | Price: $2,265
The FDA’s fast-tracking of two molecularly targeted cancer drugs signals a major shift in medicine — and the cancer therapy marketplace. Today, Pfizer and Roche have an edge with their newly approved drugs. But analysts say the flexibility of smaller companies could ultimately give them the edge in new market niches where therapies no longer focus on where the cancer is located, but the cells’ molecular make up and the patient’s genetic factors. Whether this shift represents a concern or an opportunity depends on how you navigate the next five years. Here’s how to see what’s coming — today.
Published: January 2012 | Pages: 62 | Price: $377 | ISBN: 978-1-60004-271-3
What would FDA inspectors say if they walked into your lab today and looked at your training records? Are your SOPs up-to-date and complete? Would your sample-handling procedures and archives win praise from an auditor? If you have any doubts, now is the time to take action with this 10-step approach to ensuring quality in GLP-compliant labs…
Published: January 2012 | Pages: 108 | Price: $377 | ISBN: 978-1-60004-016-6
Are you struggling to cope with negotiating dozens of supplier quality agreements? What topics need to be addressed in every quality agreement? What changes at your suppliers’ operations do you need to know about? Does every supplier even need to have a quality agreement?
Published: January 2012 | Pages: 109 | Price: $377 | ISBN: 978-1-60004-269-0
No question about it: social media presents a host of problems for drug and device companies. Still, for brands that manage their presence successfully, the upside potential is huge. But what’s the secret to keeping control over your brand as people share on social media? What does an FDA-proof social media presence look like? What happens if consumers use YouTube, Twitter or Facebook to report previously unknown adverse events? How do you present balanced promotions and important safety information using social media? Here’s how to develop a social media strategy that keeps you compliant and competitive.
Published: November 2011 | Pages: 132 | Price: $377 | ISBN: 978-1-60004-265-2
At last, the FDA has published guidance and recommendations that will take the uncertainty out of using electronic source documentation in clinical trial records. Now there are answers that will clear up the questions that for years have plagued sponsors and CROs attempting to shift to an all-electronic environment. This new report is designed especially to help you clarify the FDA’s recommendations — and put them into action. Read on.
Published: November 2011 | Pages: 85 | Price: $377 | ISBN: 978-1-60004-263-8
Here in one authoritative source is what clinical trial sponsors must know before venturing into China. This management report provides an overview of China’s current regulatory landscape and points out key differences from US and European requirements.
Published: October 2011 | Pages: 59 | Price: $397 | ISBN: 978-1-60004-259-1
To understand how life is changing, for companies operating under corporate integrity agreements, you need to look deep into the recent settlement agreements that drug and device companies are signing.
Published: October 2011 | Pages: 26 | Price: $377 | ISBN: 978-1-60004-257-7
This report is the clearest and most practical training available today for avoiding problems with off-label promotion.
Published: August 2011 | Pages: 265 | Price: $3,500
Looking for international manufacturing partners and API suppliers? The Far East is no longer your only option. Companies in Central Europe (CE) and the Balkan states are actively seeking new markets and new partnerships with Western businesses. And these outsourcers have developed capabilities, credentials and business operations that are helping them outperform established competitors in the Far East and other regions of the world. What would a new CE/Balkan firm partnership mean for you? Which CMOs and suppliers would be your best match? Country by country, what trends are complicating outsourcing … and which are opening profitable new options? Here’s the best source for information on all the most promising opportunities.