Postmarket Safety

ARTICLES

FDA Expands Opioid Prescription REMS to IR Formulations

Manufacturers of short-acting opioids will be required to offer the kind of doctor training in administering the medications that their extended-release counterparts have been directed to provide since 2012, FDA Commissioner Scott Gottlieb said. Read More

PRODUCTS

The U.S. Opioid Crisis - Webinar Recording/Transcript

$287.00
The opioid crisis is the stuff of daily headlines. But behind the headlines lurk serious implications for drugmakers, healthcare providers and other regulated firms. View

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium

$397.00
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products. View

Must-Know Contracting for Non-Lawyers - Webinar Recording/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 Young 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

Global Regulation Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

$287.00
In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View

Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript

$287.00
In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View

Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript

$287.00
In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View

What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript

$287.00
FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View

Biosimilars Regulation: The Importance of Interchangeability - Webinar CD/Transcript

$287.00
The biosimilars industry is at a crossroads known as interchangeability. Drug and biologics firms that are first to master this key concept stand to reap the greatest rewards. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

$287.00
The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View

FDA’s Big 5 Challenges - Webinar CD/Transcript

$287.00
The FDA likely will break new ground this year, posing extraordinary regulatory challenges to Rx, food and tobacco interests. Botox. Cannabis. Opioids. Tobacco intended use. State right-to-try initiatives. How will the FDA tackle these hot potatoes? View

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

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