Submissions and Approvals

ARTICLES

FDA Approves First Generic Naloxone Nasal Spray

The FDA announced full approval of Teva’s generic naloxone nasal spray—tentatively approved last June as the first generic spray for treating opioid overdoses—and said the agency will prioritize reviews of other naloxone generics and push for the development of an over-the-counter version. Read More

PRODUCTS

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

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

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