Research and Development

ARTICLES

SUBSCRIPTIONS

PRODUCTS

Inspection Intelligence: Develop a Data–Driven Approach - Webinar CD/Transcript

$287.00
To be inspection ready you must understand both the internal and external data affecting your products — and analyze and act on the data. Expert Armin Torres — Principal Software Consultant at Qualified Data Systems — discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs. View

Clinical Investigator Questions, FDA Answers

$397.00
FDAnews’ staff has culled through questions submitted to OGCP about investigations and curated more than 90 of the most relevant responses for you — segmented by category — saving you the time and frustration of sifting through the questions and responses. View

Special Protocol Assessment: Winning FDA Support for Trial Design

$397.00
The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information. View

20 Elements of Postmarket Reporting: Building Periodic Benefit-Risk Evaluation Reports

$177.00
With the 20 Elements of Postmarket Reporting brief you will learn how to prepare Periodic Benefit-Risk Evaluation Reports (PBRER) in a modular format that can be used in other postmarket surveillance reports required by the FDA and international regulators. View

Assessing the Benefit-Risk Balance in Company Core Data Sheets - Webinar CD/Transcript

$287.00
Do you know the new rules — and how to apply them — for your Company Core Data Sheets? Join Graeme Ladds — CEO of PharSafer® — for a discussion on the current guidances and rules including what stayed the same and what changed. If you just rely on your understanding of the guidance that was released four years ago, you’ll be taking a risk and not adhering to the new rules. View

New Trump Administration, New Republican Congress - Webinar CD/Transcript

$287.00
The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries? View

Top Ten Data Integrity Traps: How to Find and Fix Problems

$177.00
The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

GCP Questions, FDA Answers

$397.00
FDAnews’ staff has culled through hundreds of questions posed to OGCP and curated more than 175 of the most relevant of responses for you — segmented by category — saving you the time and frustration of sifting through the questions and responses. View

Inspections — From the Routine to the Truly Bizarre - Webinar CD/Transcript

$287.00
As you are well aware, even a routine FDA inspection can be problematic — challenging — or truly bizarre. Be prepared to deal with the challenging inspection situations that an FDA inspector may throw your way. View

Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules

$397.00
New guidances in the US and EU require drugmakers to include a pediatric component in clinical trials for any new drug that could be used to treat children as well as adults. View

Pre-Approval Inspection: Four Steps to Success

$177.00
This FDAnews Brief gives you a concise, point-by-point map to follow to pre-approval success, from developing an inspection SOP to making logistical decisions to handling investigators questions effectively, and surviving the data integrity audit. View

Special Protocol Assessments - Webinar CD/Transcript

$287.00
When should you consider pursuing an SPA? If you do, how long will it take? Join Alexander Varond — Associate at Hyman, Phelps & McNamara — for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors. View