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Publications

Published Works

These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. Life Sciences Connect

Partner Lynn Mehler and Counsel Lowell Zeta pen a guest column for Life Sciences Connect where they discuss the recent appointment of a new Center for Drug Evaluation and Research director...

Published Works

2021 Chambers Global Practice Guide in Life Sciences Chambers Global Practice Guide

A team of lawyers from Hogan Lovells contributed to the 2021 Chambers Global Practice Guide in Life Sciences. They provided legal commentary and insights on Life Sciences industry trends...

News

FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials Focus On Regulation

This morning, the U.S. Food and Drug Administration (FDA) announced it launched its new expanded access pilot called "Project Facilitate," a concierge call center under the Oncology Center...

News

FDA guidance may ease path to biosimilar interchangeability Focus On Regulation

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance, "Considerations in Demonstrating Interchangeability With a Reference Product," which is intended to...

News

Influencer Promo Guide: Best Practices for Drug and Device Firms

In our “Influencer promo guide: Best practices for drug and device firms”, we offered a list of best practices for medical device and pharmaceutical companies interested in...

Insights and Analysis

Regulatory Insights for Life Sciences and Health Care Investments: Regulatory changes in Europe

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars.

Insights and Analysis

FDA schedules public hearing on solutions to drug shortages Pharmaceuticals and Biotechnology Alert

The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers,...

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