A Challenging Regulatory Environment Means More Care Needed with FDA Submissions

In the first of a series on surviving the current financial and regulatory environment, Torrey Cope looks at how life sciences companies can reduce difficulties in getting new products approved by the U.S. Food and Drug Administration through effective written submissions.

Biden Administration Moves to Boost the Bioeconomy

A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.

Remote Regulatory Assessment Oversight Tools Piloted During the COVID-19 Pandemic Are Here to Stay

Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.

Podcast: How the EU’s New Revised Annex 1, Eudralex Volume 4 (GMP), Will Affect the Manufacturing of Sterile Medicinal Products in the EU and U.S.

Jay Jariwala in Washington, D.C. and Josefine Sommer in Brussels talk to Raj Pai about how they expect the EU’s new revised Annex 1, EudraLex Volume 4 (GMP), to affect the manufacturing of sterile medicinal products. They discuss how the update reflects changes in the manufacturing environment and how the new Annex 1 is likely to be considered within the U.S. regulatory framework. Prior to joining Sidley, Jay worked for the Office of Compliance at the Center for Drug Evaluation and Research, a branch of the U.S. Food and Drug Administration, and he brings this experience to bear in considering the impact of Annex 1.

Are China-only Clinical Trials Enough for U.S. Approvals?

Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suitable for the U.S. population, and considers the regulatory requirements for U.S. approvals based on ex-U.S. trial data.

(more…)

Key Questions To Ask When Conducting Due Diligence of an Emerging Cellular or Gene Therapy Company

Following our recent post highlighting potential compliance risks at emerging cellular and gene therapy companies, Stephen Abreu and Chris Fanelli provide some questions and topics to explore when considering an investment or acquisition in this space. (more…)

Buyer Beware: Compliance Risks at Emerging Cellular and Gene Therapy Companies

Chris Fanelli explains how emerging cellular and gene therapy companies present unique challenges and unique opportunities from a compliance perspective. He explores some of the tools that buyers can use to assess GxP compliance at the due diligence and post-acquisition stages.

(more…)

Regulators Offer Fresh Guidance on Using Real-World Data to Support Regulatory Decisions

Becky Wood in Washington, D.C., Emily Marden in Palo Alto, and Josefine Sommer in Brussels look at new FDA guidance on the use of real-world data to support new indications and post-approval study requirements.

(more…)

What Do the FDA’s Expanded ‘Intended Use’ Regulations Mean for Safe-harbored Communications about New Uses?

Prior to their webinar on Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.

FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect  since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.

(more…)