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
Kurin’s Blood Culture Contaminant Diverter Gets CE Mark
Patients may be exposed to unnecessary antibiotics because of contaminated blood cultures, the company noted.
Sanofi’s Dupixent Snags European Approval for Treating Severe Asthma
The drug offers a new treatment option for those who remain inadequately controlled with current medications.
Postmarket Safety
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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
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
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
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
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
Chinese Medicine: The Dangers of Deployment - Webinar Recording/Transcript
$287.00
Rosmary Gibson — Senior Advisor at the Hastings Center and author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine discusses the real-world impact of Chinese medicine on public health and the scrutiny it’s undergoing. View
REMS: Requirements, Regulation, and Enforcement - Webinar Recording/Transcript
$287.00
REMS has evolved into a powerful enforcement tool. FDAnews has called on Anne K. Walsh, a Washington, D.C. attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. View
