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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Four Hot Topics in FDA Regulation & Compliance - Webinar Recording/Transcript
$287.00
From opioids to biosimilars, from right-to-try to dietary supplements, controversies continue as the agency, Congress and the White House feel their way toward a new approach to life science regulation. Join noted FDA legal expert Roseann B. Termini Esq. for the real skinny on four top issues. View
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
Cell & Gene Therapy Strategies for Successful BLA Submissions - Webinar Recording/ Transcript
$287.00
Scott R. Burger, MD — Principal, Advanced Cell and Gene Therapy —discusses the FDA’s requirements for successful BLAs and how to comply and make you aware of the common mistakes and how to avoid them. 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
REMS Regulatory Developments and Best Practices - Webinar Recording/Transcript
$287.00
Lynn Mehler — partner in the Hogan Lovells pharmaceutical and biotechnology practice — will address the FDA’s current expectations in designing a program to assess REMS, and how to make your program compliant with those expectations. 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
Biosimilars Regulation - Webinar Recording/Transcript
$287.00
Nicholas Mitrokostas, partner in the Boston office of Goodwin Procter LLP and Daniel Orr, partner in the Washington, DC office of Womble Bond Dickinson LLP, will provide an overview of the FDA’s current review process, approval standards, and related issues confronting sponsors of reference biologics and biosimilars. 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
