Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
Flat Medical’s Epidural Protector Cleared by FDA
The syringe alerts anesthesiologists to the moment it has arrived at the epidural space, avoiding the risk of accidental puncture.
Gore Gains FDA Approval for Stent Graft
The graft features a staged deployment process for increased accuracy during placement.
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The FDA in a Post-Gottlieb World - Webinar Recording/Transcript
$287.00
Join us for a detailed analysis about whether the changes and reforms advanced in the past two years will remain and whether it will affect your product development and approval applications. View
The Accelerated Approval Pathway for Drugs and Biologics - Webinar Recording/Transcript
$287.00
Learn firsthand from an FDA speaker on referencing best practices for the clinical trial and the endpoint to support the accelerated approval in the product label. View
Dealing with FDA and Their Inspection Enforcement Tools - Webinar Recording/ Transcript
$287.00
John Fuson — former Associate Chief Counsel for Enforcement, FDA — will review factors that increase enforcement risks and provide insights on how enforcement progresses from inspectional observations to 483s, warning letters, seizures, injunctions and possible criminal actions or jail time. View
Pharmaceutical Data Integrity - Webinar Recording/Transcript
$287.00
Cynthia Schnedar, Executive Vice President and Liz Oestreich, Vice President — both of Regulatory Compliance at Greenleaf Health, Inc. — will offer recommendations on how to build and maintain a culture that values quality and supports data integrity in the manufacturing process. View
OTC Regulation - Webinar Recording/Transcript
$287.00
Christine Kirk — an associate in the Food and Drug Group of Arnall Golden Gregory’s healthcare practice — will discuss recent developments in OTC regulation and enforcement as well as key compliance topics. View
Outsourcing Facility Compounding - Webinar Recording/Transcript
$287.00
Lee H. Rosebush — partner at Baker Hostetler and chairman of the Outsourcing Facilities Association — will address the newly proposed outsourcing facility compounding standards and will discuss several outstanding questions the industry must confront. View
Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency
$497.00
Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency explains the agency’s integrated approach and how you can make the most of the FDA’s quality priorities and inspection procedures. View
Building a World-Class Drug Supply Chain - Webinar Recording/Transcript
$287.00
Many manufacturers have acquired the skills and capabilities necessary to “serialize” products, but they are far from efficiently running their manufacturing and supply chain operations. View
Regulating Software Used by Life Science Manufacturers - Webinar Recording/Transcript
$287.00
Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what’s not. View
Recent Developments in ICH Harmonization - Webinar Recording/Transcript
$287.00
ICH is developing guidelines to improve implementation of post-approval chemistry, manufacturing, and controls (CMC) changes, harmonization of the biopharmaceutics classification system (BCS)-based biowaivers, and bioanalytical method validation. View
Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies - Webinar Recording/ Transcript
$287.00
In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. View
Expediting the Generic Drug Approval Process - Webinar Recording/Transcript
$287.00
The FDA announced its Drug Competition Action Plan a year ago. And the agency continues to announce new guidances intended to speed up generic drug approvals. The FDA recently announced a guidance to enhance filing review requirements. Are you — and your new generic — ready for the expedited pathway? View
