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Results: 1-10 of 42

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


FDA Seizes Stem Cell TherapyA First of Many?
  • Hogan Lovells
  • USA
  • August 29 2017

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000a smallpox vaccine containing live vaccinia virus


There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act
  • Hogan Lovells
  • USA
  • August 21 2017

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support


Do the Waive - FDA Implements Informed Consent Waivers for Minimal Risk Studies
  • Hogan Lovells
  • USA
  • August 10 2017

On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some


Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators
  • Hogan Lovells
  • USA
  • July 5 2017

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA


Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical investigations
  • Hogan Lovells
  • USA
  • June 27 2017

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 Questions and Answers." The draft guidance is intended


To certify or not to certify? FDA has answered the question
  • Hogan Lovells
  • USA
  • June 13 2017

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device