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The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium - 2018

December 9, 2019

Since the 21st Century Cures Act opened the door for observational studies to join traditional clinical research in the drug and device approval process, many companies are taking the first steps into the use of real-world evidence. This new edition presents new information on the encouraging results those pioneers have found.

Strategies for Risk-Based Clinical Trial Monitoring and Inspections

December 9, 2019

You're probably on the fence about employing a risk-based clinical trial monitoring program. Many are, preferring the old methods of 100 percent verification of data - and intense site visits - that they're more familiar with. But the fact is risk-based monitoring with a centralized data monitoring component can actually produce better levels of compliance than the old ways - if it's done correctly. This FDAnews management report will show you exactly what 'done correctly' is.

Supplier Assessment Checklists: A Tool for Vetting Vendors and Contractors

December 9, 2019

What questions do you need to ask to make sure you select the best suppliers and contractors? This report includes two checklists — the API and Excipient Supplier Checklist and the Contract Manufacturing and Analysis Checklist — that will guide you through the process so that you dont have to worry about missing any points or asking the wrong questions.

Supplier Auditing: A Four-Part Plan

December 9, 2019

You need a supplier auditing program that helps you stay on top of all your outsourced operations. The FDAnews Brief Supplier Auditing: A Four-Part Plan helps you build a system that shows the FDA and other regulators that you hold the reins when it comes to supplier quality.

Supplier Quality Metrics for Devicemakers: Predicting and Selecting the Best

December 9, 2019

Medical devicemaking relies on a supply chain that often includes hundreds of companies and stretches around the globe, a network so vast that quality control can seem impossible.In this management report youll learn how to use predictive analysis of such metrics as delivery time, management efficiency and lot acceptance rate to identify suppliers you can count on and spot potential problems in the future.

Surviving an FDA Inspection: 2015 Edition

December 9, 2019

Under the FDA's new inspectorate reorganization, the agency is using specialized teams of highly trained investigators. This is making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips.

Social Media Accountability for Drug and Devicemakers: Controlling the Online Conversation

December 9, 2019

The FDA may not hold you responsible for reader comments, but they will watch for the way you respond. This management report gives you an understanding of how to use social media for product promotion without running afoul of the agency.

Social Media Strategies for Drug and Device Companies

December 9, 2019

No matter how fast the rules continue to change, this new management report will help drug- and devicemakers tap the power of social media. you'll find real-world strategies for building a strong presence on Facebook, Twitter and YouTube - without giving up control over your brand or risking marketing and advertising enforcement. With little specific guidance from the FDA, this report fills a critical gap.

Special Protocol Assessment: Winning FDA Support for Trial Design

December 9, 2019

A new FDA draft guidance gives drug sponsors detailed advice on how to take advantage of the opportunity to have agency staff review your protocol before you begin your trial. This management report explains what kinds of trials are eligible, how the process works and what to do if the FDA doesnt agree with your plans.

Strategies for Biosimilars Approval: A Map to 351(k) Success

December 9, 2019

Want to know how Sandoz was the FDA's first biosimilar approval? Learn how Sandoz navigated the agency's approval process. FDAnews has a new management report that will give you candid "what to do - and how to do it" advice. Discover how to minimize the amount of time it takes to get your biosimilars approved - so you can speed your product to market and maximize your revenue generating potential.

Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices

December 9, 2019

This report will show you, step-by-step, how to properly design and implement your risk-based clinical trial monitoring program to fully satisfy the FDAs requirements. You'll get specific recommendations about the 5 data points that you must always monitor … 9 essential critical risk factors your monitoring plan must consider … 5 key components that should make up your monitoring plan (and what they each should contain) … and all of the documentation requirements that are absolutely essential to every monitoring plan.

Root Cause Analysis for Drugs and Devices

December 9, 2019

This management report provides a step-by-step guide to conducting an effective root cause analysis, from recognizing problems that need to be investigated to documenting the investigation so regulators can see you are on top of the situation. The report also includes root cause analysis templates readers can customize for their own investigation.