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Results: 1-10 of 48

FDA aims to foster gene therapy developments with six new draft guidance documents
  • Hogan Lovells
  • USA
  • July 11 2018

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


A new right for American patients: The Right to Try
  • Hogan Lovells
  • USA
  • May 25 2018

On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the "Right to Try Act of 2017" by a vote of 250-169. The


FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk
  • Hogan Lovells
  • USA
  • May 11 2018

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell


FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials
  • Hogan Lovells
  • USA
  • April 18 2018

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies


Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
  • Hogan Lovells
  • USA
  • February 14 2018

The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws


FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products
  • Hogan Lovells
  • USA
  • January 26 2018

FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall


The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns
  • Hogan Lovells
  • USA
  • January 5 2018

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcellan adipose tissue derived stem cell


FDA Simplifies and Clarifies Expanded Access Program
  • Hogan Lovells
  • USA
  • October 9 2017

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program


Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate Sterility Assurance
  • Hogan Lovells
  • USA
  • September 20 2017

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine


Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump’s Regulatory Reform Executive Orders
  • Hogan Lovells
  • USA
  • September 8 2017

Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771