News & Analysis as of

Food and Drug Administration (FDA) Japan

King & Spalding

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 6

Hogan Lovells on

In Washington: The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on Friday lifted the recommended pause on the use of Johnson & Johnson’s coronavirus vaccine, saying the benefits...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

In Tuesday's Report: the expanding role of real-world evidence in FDA medical device submissions; President-elect Joe Biden lays out COVID-19 plan; Pfizer announces vaccine efficacy; and an analysis of material adverse change...more

Morrison & Foerster LLP

MoFo Japan Disputes Newsletter – 4th Quarter 2020

Welcome to the inaugural edition of Morrison & Foerster’s quarterly newsletter on recent developments in arbitrations, investigations, and commercial and intellectual property litigation that may affect Japanese companies. ...more

ArentFox Schiff

New Clinical Data Not Encouraging for Chloroquine and Hydroxychloroquine as COVID-19 Treatment: FDA and NIH Expert Panel Speaks...

ArentFox Schiff on

The latest clinical data casts doubt on the safety and efficacy of these antimalarial drugs for treatment of COVID-19, and both the FDA and an Expert Panel of the NIH have just warned against their use outside of clinical...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2020

USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies - On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more

Goodwin

Biosimilar Regulatory Submission Updates: Europe, U.S., Japan, Canada

Goodwin on

Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of...more

7 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide