Submissions and Approvals

ARTICLES

PRODUCTS

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

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

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