Remarks by Commissioner Hahn to the Compounding Quality ...
2 days ago - Remarks by Stephen Hahn, M.D., Commissioner of Food and Drugs, to the Compounding Quality Center of Excellence Conference, Sept. 21, 2020, White Oak, ..
Wednesday, September 23, 2020
Tuesday, September 22, 2020
Walmart piloting drone delivery for COVID-19 self-swab kits
By Paige Minemyer
Walmart is piloting drone delivery of home sample collection kits for COVID-19 in partnership with Quest Diagnostics.
| 09/22/2020 | 09/11/2020 | Lucid Liquids | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| 09/22/2020 | 09/10/2020 | Integrated Health Concepts Inc. dba Conversio Health | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products |
| 09/22/2020 | 09/10/2020 | HNC Products Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated |
| 09/22/2020 | 09/08/2020 | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products |
| 09/22/2020 | 09/04/2020 | DN Imports, Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| 09/22/2020 | 07/31/2020 | Provape Enterprise, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 09/22/2020 | 07/31/2020 | Ejuicesteals.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 09/22/2020 | 08/17/2020 | Vape Central Group, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 09/22/2020 | 08/27/2020 | The Vapor Island Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 09/22/2020 | 09/04/2020 | Apocalypse Juice, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
Today, we proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the “intended use” of a product. A product’s intended use determines whether it is a medical product within the scope of FDA’s jurisdiction. This proposed rule, Amendments to Regulations Regarding “Intended Uses,” is an important step forward in fulfilling our public health mission and our promise to provide better clarity to regulated industry and other stakeholders.
The proposed revisions to the intended use regulations do not reflect a change in the FDA’s policies and practices, but rather seek to clarify the regulatory language describing the types of evidence we consider relevant to determining a product’s intended uses. The purpose of our...
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