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 519

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) pathway for certain devices
  • Hogan Lovells
  • USA
  • April 19 2018

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft


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In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies


FDA Commissioner Gottlieb Announces New Nutrition Innovation Strategy
  • Hogan Lovells
  • USA
  • April 5 2018

On March 29, 2018, Food and Drug Administration (FDA or the agency) Commissioner Scott Gottlieb, M.D., delivered a nutrition-related policy address


FSMA Implementation Update (March 2018)
  • Hogan Lovells
  • USA
  • March 26 2018

There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). This memorandum summarizes the


FDA Publishes List of All General FDA Form 483 Inspection Citations for Every Food Facility Since 2008
  • Hogan Lovells
  • USA
  • March 23 2018

The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483


FDA Publishes List of FSVP Importers Under FSMA
  • Hogan Lovells
  • USA
  • March 19 2018

The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in


Obtaining FDA clearance or approval of digital health products
  • Hogan Lovells
  • USA
  • March 14 2018

Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a


Checking in with the FTC’s Bureau of consumer protection - trends, highlights, new developments and what lies ahead
  • Hogan Lovells
  • USA
  • February 28 2018

The Federal Trade Commission (FTC) Bureau of Consumer Protection is where the action is when it comes to identifying current and future trends related


DOJ Memoranda Limit the Use of Guidance Documents in Civil Actions
  • Hogan Lovells
  • USA
  • February 27 2018

As seen in news reports, two recent Department of Justice (DOJ or Department) memoranda address the role of guidance documents in civil enforcement


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