Regulatory Affairs

ARTICLES

PBMs Deny Link Between Price Hikes and Rebates

Drug manufacturers set higher prices even when rebates for pharmacy benefit managers decrease, contradicting allegations that rebates may help drive the increases, according to a new report released by the Pharmaceutical Care Management Association (PCMA). Read More

PhRMA Hits Governors’ Ideas for Drug Price Cuts

PhRMA slammed a new report from the National Governors Association laying out strategies governors are considering to lower drug prices — including the use of value-based pricing, a cap on Medicaid spending and more price transparency. Read More

PRODUCTS

GDP Audit Checklist: Meeting Global Transport and Storage Requirements

$230.00
GDP Audit Checklist: Meeting Global Transport and Storage Requirements is written by Simone Ferrante, Head of Quality & Regulatory Affairs for Grieshaber Logistics Group AG, Bad Säckingen. She implemented the company’s GDP/GMP-compliant quality management system. View

Complying with Advertising & Promotion Requirements - Webinar Recording/Transcript

$287.00
From Washington (the FDA, the FTC) to the states (attorneys general) to City Hall, dozens of agencies take an interest in the way you advertise and market your products. Take a crash course in dealing with this panoply of enforcers. 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

Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC

$397.00
Order your copy of Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC and know how to handle hot spots in advertising and promotion while avoiding warning letters and other enforcement actions. 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

Five-Volume Drugs/Biologics Title 21 CFR Set 2018

$300.00
The federal government has compiled the new 2018 CFR volumes. View

Nine-Volume Title 21 CFR Set 2018

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






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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