Submissions and Approvals

ARTICLES

PRODUCTS

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The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information.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

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

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at Hyman, Phelps & McNamara — for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors.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

False Claims Act Liability for Regulatory Noncompliance - Webinar CD/Transcript

$287.00
The Department of Justice’s interim final rule virtually doubles penalities for those that violate the False Claims Act. How can you avoid liability under the FCA? Join Anna Laakmann — Counsel, Greenberg Traurig — explains how regulatory noncompliance can form the basis of an FCA enforcement action by the government. View

Training Staff to Detect Data Integrity Issues - Webinar CD/Transcript

$287.00
Over the past few years, global regulators have increased their focus on data integrity systems. Who is responsible for data integrity? Find out in this 90-minute presentation. View

OTC Labeling and Advertising - Webinar CD/Transcript

$287.00
What are the most significant new developments that marketers of OTC drugs face? Stacey Erhlich and Will Woodlee — Partners at Kleinfed, Kaplan & Becker, LLC — discuss what OTC drug products require premarket approval, labeling and promotion rules, and common but avoidable mistakes in marketing OTC drug products. View

Pediatric Clinical Trials Regulation - Webinar CD/Transcript

$287.00
What do you need to know about upcoming regulation changes to pediatric trials and drug development? Dr. Martine Dehlinger-Kremer — Global Vice President, Medical & Regulatory Affairs at SynteractHCR — helps attendees understand the landscape for pediatric drug development. View

Spreadsheet Validation 2016 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View