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Results: 1-10 of 170

FDA inspection proposal provides valuable insight into scope of investigations
  • Keller and Heckman LLP
  • USA
  • April 18 2018

At yesterday’s meeting with the U.S. House Subcommittee on Agriculture and Rural Development to discuss FDA’s Fiscal Year 2019 budget, Food and Drug


Revised FDA Ingredient Listing Guidance for Tobacco Products Published, Exempts Non-Consumable Product Hardware and Components and Parts From Section 904(a)(1) Listing Requirement
  • Keller and Heckman LLP
  • USA
  • April 16 2018

The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing


May 5, 2018 Deadline for eCTD Submissions for DMFs Around the Corner
  • Keller and Heckman LLP
  • USA
  • April 10 2018

The Food and Drug Administration's (FDA) requirement for Electronic Common Technical Document (eCTD) formatting for all submissions associated with


FDA Issues First Ever Mandatory Recall Order for Kratom Products
  • Keller and Heckman LLP
  • USA
  • April 4 2018

On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle


Consent Decree of Permanent Injunction Against Wholesale Manufacturer of Dietary Supplements
  • Keller and Heckman LLP
  • USA
  • April 2 2018

In a March 29, 2018 press release, the Food and Drug Administration (FDA) announced a consent decree entered by the US District Court for the Eastern


FDA’s May 8, 2018 Ingredient Listing Deadline Approaching for Large Manufacturers of Deemed Tobacco Products; New FDA eSubmitter Instructions and Ingredient Spreadsheets Now Available
  • Keller and Heckman LLP
  • USA
  • April 2 2018

Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco


FDA Issues First Warning Letter Based on “Serious Violations” of Part 117 CGMP Regulations
  • Keller and Heckman LLP
  • USA
  • March 30 2018

On March 16, 2018, FDA issued a warning letter to Bhavani Fruits and Vegetables LLC in Maspeth, New York for “serious violations” of Current Good


FDA Issues Advanced Notice of Proposed Rulemakings Regarding Premium Cigars and Tobacco Product Flavors
  • Keller and Heckman LLP
  • USA
  • March 26 2018

In FDA’s latest effort to implement its comprehensive plan for tobacco and nicotine regulation, the Agency published two additional advanced notice of


FDA Guidance States Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulations
  • Keller and Heckman LLP
  • USA
  • March 21 2018

On March 21, 2018, the U.S. Food and Drug Administration (FDA) published guidance that live animals processed under Department of Agriculture (USDA


FDA Issues Advanced Notice of Proposed Rulemaking on Potentially Lowering Nicotine Levels in Combustible Cigarettes to Minimally or Non-Addictive Levels
  • Keller and Heckman LLP
  • USA
  • March 15 2018

In the U.S. Food and Drug Administration’s (FDA’s) latest effort to implement its comprehensive regulatory plan to shift the trajectory of