Research and Development

ARTICLES

FDA, OHRP Finalize Guidance on IRB Meeting Minutes

The FDA and the HHS Office of Human Research Protections finalized their joint guidance detailing requirements for keeping minutes of institutional review board meetings, as part of a push to harmonize research regulations across the government before 2020. Read More

SUBSCRIPTIONS

PRODUCTS

Expanded Access at a Crossroads - Webinar Recording/Transcript

$287.00
Expanded Access is the hottest topic in new-drug development, and now the FDA appears ready to loosen the reins. View

Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation

$397.00
In Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation noted FDA law expert Jim O’Reilly lays out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it. View

ClinicalTrials.gov: Mastering New Reporting Rules

$397.00
ClinicalTrials.gov: Mastering New Reporting Rules parses out the rules provisions, explaining who must report what — what information they must submit — what deadlines are — and what could happen if they miss the mark. 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

Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy

$397.00
Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy explores the draft guidances and other FDA activity on the subject of promotional communication — explaining what companies must do to stay on the right side of the agency’s new policies and how to take advantage of the opportunities they present. View

Implementing Elemental Impurities Testing - Webinar CD/Transcript

$287.00
A little more than a year ago, a paradigm shift occurred in testing for elemental impurities. The then-new ICH Q3D guideline established tough new expectations for new drugs. 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

Navigating New Terrain in Advertising and Promotion of Medical Products - Webinar CD/Transcript

$287.00
The rules on drug and device marketing are changing. In the absence of settled policy, your safe harbor lies in following the terms of three draft FDA guidances. View