Submissions and Approvals

ARTICLES

FDA Approves First EpiPen Generics

Commissioner Scott Gottlieb said the approval is part of FDA’s “longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.” Read More

PRODUCTS

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

FDA’s New Concept of Operations for Drug Inspections & Evaluations - Webinar Recording/ Transcript

$287.00
ConOps is the acronym for a soon-to-take-place FDA restructuring that’s certain to affect drug inspections going forward. How will the agency’s new vertically integrated, programmatically aligned environment affect the new roles and responsibilities of CDER and ORA? View

Top Tips for Dealing with the FDA - Webinar Recording/Transcript

$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View

Precision Medicine: Challenging the Regulatory Landscape - Webinar Recording/Transcript

$287.00
“Precision Medicine,” a/k/a “Personalized Medicine,” promises a new and rich path to drug and device profits. But a top Washington FDA lawyer offers a list of precautions as you take the plunge. View

The Fast Track to Drug Approval: Five FDA Pathways for Expedited Review

$397.00
The FDAnews report The Fast Track to Drug Approval outlines the five pathways — Fast-Track Designation, Breakthrough Therapy Designation, Regenerative Advanced Therapy Designation, Priority Review and Accelerated Approval. View