Commercial Operations

ARTICLES

Retail Giants Sue Bausch and Others Over Glumetza

Walgreens and other big name retailers have filed an antitrust suit against Bausch Health, its subsidiaries, and generic drugmaker Lupin for allegedly plotting to hike the price of Bausch’s diabetes drug Glumetza and Lupin’s generic version. Read More

PRODUCTS

Organizing Data and Document Archives – Webinar Recording/Transcript

$287.00
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

The Future of Generic Drug Competition – Webinar Recording/Transcript

$287.00
Current and future measures by FDA and Congress to incentivize generic drug competition will have enormous impact on how quickly your drug gets to market. What does this mean for 180-exclusivity? How can you obtain expedited approval and related marketing exclusivities? View

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

Regenerative Medicine and Stem Cell Regulation – Webinar Recording/Transcript

$287.00
If you find the FDA’s regulatory framework regarding regenerative medicine and stem cell therapies confusing, you’re not alone. A noted expert is here to explain the current regulatory framework and FDA’s interpretation, enforcement actions not only from FDA but FTC and the states, and opportunities for the legal development and use of stem cells. View

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