Area of focus

Cell, Tissue, and Gene Therapies

You create new products at the speed of innovation. And regulators race to keep pace. Commercial success and compliance can sometimes seem at odds.

The lawyers at Hogan Lovells uncover opportunity and mitigate risk for clients regarding cell, tissue, and gene therapies. From responding to U.S., EU, and Asian regulators, to ...

Representative experience

We have advised human tissue companies on how to transition a product from 361 HCT/P status to licensure as a biologic under section 351 of the Public Health Service Act.

We have assisted leading pharmaceutical companies in determining the appropriate classification of their tissue products in the EU.

We have advised gene therapy companies on genotyping programs.

We obtained Healthcare Common Procedure Coding System (HCPCS) codes for cellular therapies.

Assisted a client developing a gene therapy product for an orphan condition convince FDA to relinquish burdensome clinical trial endpoint requirements.

Counseled a gene therapy company and a company developing a drug to treat genetic obesity on genotyping programs and subject recruiting and patient identifying programs.

Counseled U.S. biotech companies seeking EU marketing authorization for advanced medicinal therapies, including issues involving clinical trials and patient identification.

Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Cell and Gene Therapies

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.

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Blog Post

FDA aims to foster gene therapy developments with six new draft guidance documents

This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease...

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Blog Post

FDA shows that it means business in stopping stem cell clinics that put patients at risk

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic...

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Blog Post

The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and...

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FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited...

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