News & Analysis as of

Life Sciences Draft Guidance Coronavirus/COVID-19

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Hogan Lovells

FDA plans to expand remote evaluations, record reviews post-pandemic

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency (PHE) ends. This guidance...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies - January 2022

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2020

Goodwin on

As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory,...more

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