We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 45

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In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies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FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products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FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall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


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