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Results:1-10 of 35

FDA Issues Draft Guidance Encouraging Innovative Approaches to Expand Access to OTC Drugs
  • Kelley Drye & Warren LLP
  • USA
  • July 30 2018

FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that


FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration
  • Kelley Drye & Warren LLP
  • USA
  • July 2 2018

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA


FDA Releases First in Series of Draft Guidances Regarding Mitigation Strategies to Protect Against Intentional Adulteration
  • Kelley Drye & Warren LLP
  • USA
  • July 2 2018

On June 20, 2018, the Food and Drug Administration (“FDA”) released draft guidance for companies required to comply with the FDA’s final rule


FDA to Hold Public Meeting on Foods Produced Using Animal Cell Culture Technology
  • Kelley Drye & Warren LLP
  • USA
  • June 20 2018

The FDA recently announced that it will hold a public meeting entitled, “Foods Produced Using Animal Cell Culture Technology,” on July 12, 2018 to


USDA and FDA Announce Proposed Bioengineered Disclosure Rules and Labeling Rule Compliance Date Changes
  • Kelley Drye & Warren LLP
  • USA
  • May 15 2018

Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4


FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
  • Kelley Drye & Warren LLP
  • USA
  • January 24 2018

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved


FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
  • Kelley Drye & Warren LLP
  • USA
  • January 24 2018

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved


“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report
  • Kelley Drye & Warren LLP
  • USA
  • October 2 2017

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the


FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements
  • Kelley Drye & Warren LLP
  • USA
  • June 13 2017

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition


Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling
  • Kelley Drye & Warren LLP
  • USA
  • April 13 2017

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as