Postmarket Safety

ARTICLES

GAO Flags How a REMS May Slow Generics

Generic drugmakers have acknowledged to the GAO that their inability to access samples of reference drugs because of distribution limitations under certain risk evaluation and mitigation strategies (REMS) delayed or discouraged them from developing generic drugs. Read More

Dr. Reddy’s Suspends Global Sales of Ranitidine

Dr. Reddy’s has become the latest company to halt worldwide sales of the heartburn medication ranitidine as multiple regulatory authorities continue to investigate reports of the probable carcinogen, NDMA, in the products. Read More

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

Pharma Regulation in 2020 – Webinar Recording/Transcript

$287.00
What pharma regulatory issue will have the greatest impact on you in 2020? This presentation is your crystal ball into how the key regulatory and related issues affecting pharmaceutical quality, regulatory and compliance specialists will be addressed by the FDA in 2020. View

Increase Compliance, Reduce Risk with Integrated Digital Solutions – Webinar Recording/ Transcript

$287.00
Your connected technology — the integration of your electronic document management, training management, risk mitigation, risk management, deviation and CAPA management, and audit management systems — will trigger the kinds of checks and balances across systems that increase compliance and reduce risk. View

FDA 483s, Warning Letters & Enforcement Trends – Webinar Recording/Transcript

$287.00
How should you prepare for your next inspection? The answer, hiding in plain sight, lies in the analysis of recent FDA enforcement trends. And who better to guide you than top Washington FDA lawyers Chalana Damron Esq. and John Fuson Esq. of Crowell & Moring LLP. View

Develop World-Class SOPs that Minimize Human Error – Webinar Recording/Transcript

$287.00
Human Error Solutions’ CEO, Ginette Collazo, Ph.D. — an industrial-organizational psychologist and one of the world’s few human error reduction experts — will explain how to write and get SOPs that minimize human error. View

Labeling for Prescription Drugs, Biologics and Combination Products – Webinar Recording/ Transcript

$287.00
What implications does the recent Instructions for Use (IFU) guidance have on your new drug applications and biologics license applications? Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it. View

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.






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

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