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Results: 1-10 of 16

FDA Publishes Action Plan Designed to Address Generic Drug Competition Barriers
  • Arent Fox LLP
  • USA
  • June 28 2017

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have


DEA Denies Marijuana Rescheduling Petition, Eases Research Restrictions
  • Arent Fox LLP
  • USA
  • August 16 2016

Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of


FDA keeps up with the Kardashians, warns drug maker on social media posts
  • Arent Fox LLP
  • USA
  • September 1 2015

Recently, the Food and Drug Administration's (FDA) Office of Prescription Drug Promotion issued a Warning Letter to drug maker Duchesnay, Inc., after


US District Court affirms First Amendment protection of off-label drug promotion
  • Arent Fox LLP
  • USA
  • August 17 2015

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA's regulation of off-label


FDA issues Warning Letter to Skin Authority
  • Arent Fox LLP
  • USA
  • April 10 2015

The US Food and Drug Administration (FDA) recently sent a Warning Letter to Skin Authority, LLC, due to marketing claims used by the company to


FDA issues Warning Letter to L’Oreal for skin pigmentation claims
  • Arent Fox LLP
  • USA
  • March 3 2015

Recently, the US Food and Drug Administration (FDA) issued a Warning Letter to L'Oreal USA for marketing its cosmetic products, "Rosalic AR Intense"


FDA guidance exempts low-risk wellness products from device regulation
  • Arent Fox LLP
  • USA
  • February 4 2015

The US Food and Drug Administration (FDA) recently issued a draft guidance document announcing that it does not intend to regulate low-risk products


Human cells and tissues: FDA steps up oversight
  • Arent Fox LLP
  • USA
  • January 29 2015

The last decade has seen enormous growth in the human tissue products industry, following the Food and Drug Administration's (FDA) establishment, in


The FDA publishes Draft Guidance on CGMPs for combination products
  • Arent Fox LLP
  • USA
  • January 27 2015

The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for


FDA maintains strong enforcement stance on drug residues in food animals
  • Arent Fox LLP
  • USA
  • December 18 2014

In recent weeks, the Food and Drug Administration (FDA) has issued approximately 12 Warning Letters to dairy farms in the US due to the presence of