Commercial Operations

ARTICLES

Janssen Sues Samsung Bioepis to Block Remicade Biosimilar

Janssen has filed suit in a New Jersey federal court, hoping to delay a recently approved Remicade biosimilar from entering the market — while the biosimilar’s developer, Samsung Bioepis, bets on an upcoming U.S. Supreme Court decision going its way. Read More

Health Canada Proposes Updates to Drug Pricing Framework

Health Canada is proposing changes to its prescription drug pricing regulations with the establishment of a risk-based approach, applying new economic factors in the decision framework, and updating the list of countries it uses for average price comparisons. Read More

PRODUCTS

Disinfectant Testing and Validation - Webinar CD/Transcript

$287.00
Keeping cleanrooms clean takes more than soap and water. A lot more. It’s a complicated — but critical — topic for drug, device, biologics and supplement makers, and compounders too. View

Best Practices in Food Process Labeling & Regulation - Webinar CD/Transcript

$287.00
A strong health claim can send your products flying off the shelves. But go too far and you risk sanctions from the FDA, FTC and USDA to state and local health departments, not to mention the ire of consumer groups and their well-paid lawyers. Here’s how to stay on the safe side of the line. View

Brexit and Life Sciences Companies - Webinar CD/Transcript

$287.00
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). FDAnews has invited global drug-and-device expert Michael Burke Esq. to share his crystal ball. As law his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade, Mr. Burke is uniquely qualified. View

Supplier Contracts for Non-Lawyers - Webinar CD/Transcript

$287.00
When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Stevens Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. View

Investigations Operations Manual 2017

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2017. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Nine-Volume Title 21 CFR Set 2017

$585.00
The federal government has compiled the new 2017 CFR volumes.






View

Industry Trends and Best Practices for the Cleanroom Environment - Webinar CD/Transcript

$287.00
Cleanrooms are complicated. Product selection, rotating disinfectants, applying disinfectants and controlling bioburdens and residues are all part of the job. But what is the best way to handle it all? View

The 21st Century Cures Act & Regenerative Medicine - Webinar CD/Transcript

$287.00
The biologics license application (BLA) is perhaps the most burdensome and lengthy premarket review process that the FDA imposes. To address that, Congress created the Regenerative Advanced Therapy (RAT) designation. View

Conducting an Internal Audit for Pharmaceutical and Medical Device Companies - Webinar CD/Transcript

$101.00
Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant. Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes. View

The Reality of Doing Business in Cuba in 2017 - Webinar CD/Transcript

$287.00
Join Jennifer Diaz — a board certified international attorney — as she discusses the realities of doing business in Cuba including whether the new Trump administration will continue with efforts to open up Cuba to U.S. business or if we will see a return to the more closed and distant relationship of the past. View

Off-Label Drug Promotion - Webinar CD/Transcript

$287.00
The FDA allows manufacturers to engage in off-label communications under certain circumstances including: responses to unsolicited requests — through sponsorship of continuing medical education events where off-label uses are discussed — peer-reviewed journal articles — medical texts — and clinical practice guidelines containing off-label information. Join legal expert Alan Minsk — of Arnall Golden Gregory — as he discusses the FDA’s latest rules on what speech is and is not protected. View