Regulatory Affairs

ARTICLES

WHO Calls for GMPs to Limit Wastewater-Driven Superbugs

The World Health Organization released draft guidelines advising regulators to test the wastewater of drug plants to keep antibiotics out of the environment—and it says wastewater treatment should be part of good manufacturing practices. Read More

FDA Offers Advice for Topical OTCs

The agency says it will work hard to keep the minutes confined to “a summary of general concepts that were discussed, while excluding information” that might reveal a company’s important secrets. Read More

FDA Offers Advice on When to File and ANDA or 505(b)(2) Application

The FDA is willing to be flexible because the regulations outlining the content of an ANDA “do not describe the type or amount of information that an ANDA applicant must submit to demonstrate” that the active ingredient in the proposed generic drug product is the same as the active ingredient in the reference drug. Read More

FDA Discusses Pilot Program for Single Patient INDs

The FDA said it plans to reach out to drug manufacturers that turn down oncologists’ requests for single patient investigational new drugs (INDs) through a pilot program designed to restructure applications for expanded access. Read More

PRODUCTS

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