Research and Development

ARTICLES

FDA Offers Advice to Sponsors of ADHD Drugs

The FDA released a draft guidance for sponsors of stimulant drugs for treating attention deficit hyperactivity disorder (ADHD) with recommendations for clinical trials and new drug applications. Read More

FDA Asked How to Unblind Blood Cancer Trials

Drug companies and a contract research organization are urging the FDA to sharpen its recommendations on how to reveal to blood cancer patients whether they’re taking placebos or the real thing in clinical trials. Read More

SUBSCRIPTIONS

PRODUCTS

Real World Evidence and Data – Webinar Recording/Transcript

$287.00
Dr. Mary Jo Lamberti — associate director of sponsored research at the CSDD — and Francis Kendall — senior director at Cytel — will share critical factors you need to consider in using RWE and provide insight into the current and planned uses of RWE to support development and post-approval safety studies. View

Drug Pricing and Reimbursement – Webinar Recording/Transcript

$287.00
The drug pricing and reimbursement landscape is changing dramatically. Understanding the current policies — and proposed changes — and how to apply them to product development and commercialization plans will greatly impact the success of your products. View

Data Integrity – Webinar Recording/Transcript

$287.00
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View

Nine-Volume Title 21 CFR Set 2019

$585.00
The federal government has compiled the new 2019 CFR volumes.






View

Organizing Data and Document Archives - Webinar Recording/Transcript

$487.00
Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View

Extractables and Leachables: 101 - Webinar Recording/Transcript

$287.00
Driven by ICH Q3D guideline compliance requirements, plus a substantial shift in metal impurity standards, the FDA now expects compliance in nearly all dosage forms; and scrutiny extends to materials such as manufacturing equipment and dosing devices.  View

Perform Effective Investigations and CAPAs - Webinar Recording/Transcript

$287.00
The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size. View

Secure and Accelerate Product Approvals - Webinar Recording/Transcript

$287.00
Join FDA legal experts Greg Levine, Esq. and Kelly Combs, Esq. as they clarify the advantages of qualifying for an expedited FDA approval program, what it takes to qualify and how to secure the benefits. View

Implementing a Risk-Based Cleaning and Disinfection Program - Webinar Recording/ Transcript

$287.00
Unless you are completely up to date with relevant cleaning and disinfection industry guidance documents, regulations and auditor findings… your current program may be in trouble. View
IOM-IMAGECOVER

Investigations Operations Manual 2019

$377.00
The Investigations Operations Manual is the primary policy guide for FDA investigations and directs the conduct of all fundamental field investigational activities. View

Spreadsheet Validation - Webinar Recording/Transcript

$287.00
Perch on the shoulder of an expert to discover potential pitfalls and innovative approaches. Get feedback, resolve pain points and share experiences in real time. View

Four Hot Topics in FDA Regulation & Compliance - Webinar Recording/Transcript

$287.00
From opioids to biosimilars, from right-to-try to dietary supplements, controversies continue as the agency, Congress and the White House feel their way toward a new approach to life science regulation. Join noted FDA legal expert Roseann B. Termini Esq. for the real skinny on four top issues. View