Regulatory Affairs

ARTICLES

Pelosi Unveils Drug Pricing Bill

House Speaker Nancy Pelosi on Thursday released her much-anticipated drug pricing bill that would allow the government to negotiate drug prices directly with drug manufacturers. Read More

Senators Call on FTC to Probe Pharma Mergers

Nine senators — including eight democrats and one independent — have urged the Federal Trade Commission to “closely scrutinize” AbbVie’s proposed $63 billion merger with Allergan and Bristol-Myers Squibb’s proposed $74 billion merger with Celgene. 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

Using IT to Improve Data Integrity – Webinar Recording/Transcript

$287.00
Is IT a fully vested member of your data integrity team?  The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit. View

FDA and EU Inspections – Webinar Recording/Transcript

$287.00
It’s been seven years since FDASIA was enacted and the path to globalized GMP inspections of drugmakers is complete at last. The Mutual Recognition Agreement (MRA) provides for inspection cooperation among the FDA and the 28 member nations of the EU. What happens now??? 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

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

Five-Volume Drugs/Biologics Title 21 CFR Set 2019

$300.00
The federal government has compiled the new 2019 CFR volumes. View

Nine-Volume Title 21 CFR Set 2019

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






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EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU…

$135.00
The report covers critical elements of the product and process flow, strategies and tools a qualified person can use to manage supply chain, import, technical agreements and delegation. View