Postmarket Safety

ARTICLES

Online Pharmacy Urges FDA to Pull All Ranitidine Products

An online pharmacy petitioned the FDA to recall and suspend the sale of all ranitidine-containing products in the U.S., raising alarms after its tests of the drug detected high levels of NDMA impurities across multiple manufacturers and dosage forms. Read More

PRODUCTS

Medical Product Off-Label Use and Marketing – Webinar Recording/Transcript

$287.00
Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you. View

Drug Regulation in China - Webinar Recording/Transcript

$287.00
Do you do business in China? With the fluidity — and uncertainty — of today’s regulatory environment, you must understand exactly what China has implemented, what is pending and what the near future holds. View

Understanding the Drug Supply Chain Security Act – Webinar Recording/Transcript

$287.00
As the Drug Supply Chain Security Act’s (DSCSA) key requirements continue to take effect, FDA has begun enforcement. If you must comply with DSCSA’s implementation requirements, this presentation can’t be missed. You’ll be updated on implementation processes to gain a clear understanding of the guidelines’ nuances and tactics to avoid problem areas. 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

Nine-Volume Title 21 CFR Set 2019

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






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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

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
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

The FDA in a Post-Gottlieb World - Webinar Recording/Transcript

$287.00
Join us for a detailed analysis about whether the changes and reforms advanced in the past two years will remain and whether it will affect your product development and approval applications. View

Dealing with FDA and Their Inspection Enforcement Tools - Webinar Recording/ Transcript

$287.00
John Fuson — former Associate Chief Counsel for Enforcement, FDA — will review factors that increase enforcement risks and provide insights on how enforcement progresses from inspectional observations to 483s, warning letters, seizures, injunctions and possible criminal actions or jail time. View