Postmarket Safety

ARTICLES

FDA Limits Use of Keytruda and Tecentriq

Keytruda’s new indication is for treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 (Combined Positive Score ≥ 10), or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Read More

PRODUCTS

FDA’s New Biosimilars Plan - Webinar Recording/Transcript

$287.00
To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market. FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what you need to know about the FDA’s Biosimilars Action Plan — what the FDA is thinking, where the industry is heading, and how you can gain competitive advantage. View

Quality Metrics Redux - Webinar Recording/Transcript

$287.00
The FDA began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect — and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation. View

The CDER Reorganization: What It Means for Drugmakers - Webinar Recording/Transcript

$287.00
Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research. View

Pharmacy Compounding Regulation - Webinar Recording/Transcript

$287.00
What can you expect from the FDA’s 2018 Compounding Priorities Plan? View

What CDER Can and Can’t Do: An Inside Look from an Agency Official - Webinar Recording/Transcript

$287.00
CDER, the FDA’s drug-approval arm, pays attention to patient and caregiver input … and so should you. Dr. Khatri shows you what CDER has done, what it wishes to do, and what law and regulation prevent it from doing. View

Corporate Compliance & Liability - Webinar Recording/Transcript

$287.00
It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View

Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript

$287.00
What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View

Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript

$287.00
The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View

eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript

$287.00
Drug and biologics makers have dodged a bullet — twice — on electronic filings (eCTD) of INDs, DMFs, ANDAs, NDA, and BLAs. But the new deadline — May 5, 2019 — will be here before you know it. View

Nine-Volume Title 21 CFR Set 2018

$585.00
The federal government has compiled the new 2018 CFR volumes.






View

Investigations Operations Manual 2018

$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 2018. View

Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript

$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View