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FDA

Advocacy Submits Comments to FDA on PMTA Proposed Rule

Office of Advocacy Nov 29, 2019

On November 27, 2019, the Office of Advocacy submitted comments to the Food and Drug Administration (FDA) asserting that the agency improperly certified the Tobacco Product Applications and Recordkeeping Requirements Proposed Rule. The…

Alerts Archive

FDA Premarket Tobacco Product Applications and Recordkeeping Requirements Comment Period Reopened

Office of Advocacy Nov 26, 2019

On November 26, 2019, the Food and Drug Administration (FDA) published the proposed rule Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period. The FDA has reopened the comment period for…

Alerts Archive

FDA Seeks Comments on Premarket Tobacco Product Applications Proposed Rule

Office of Advocacy Oct 1, 2019

On September 25, 2019, the Food and Drug Administration (FDA) published the proposed rule “Premarket Tobacco Product Applications and Recordkeeping Requirements.” The proposed rule establishes the requirements for the content and form of…

Agency Roundtables

SBA Office of Advocacy – Roundtable on the Regulation of Premium Cigars – September 12,…

Office of Advocacy Aug 27, 2019

The U.S. Small Business Administration Office of Advocacy will hold a roundtable to discuss the regulation of premium cigars beginning at 10:00 a.m. on Thursday, September 12, 2019. The roundtable will be held in Washington, D.C., at the…

Alerts Archive

FDA Requests Comments for Scientific Data and Information About Products Containing Cannabis or…

Office of Advocacy Jun 11, 2019

On April 3, 2019, the Food and Drug Administration (FDA) published a request for comments for scientific data and information about products containing cannabis or cannabis-derived compounds (84 Fed. Reg. 12969). The Agriculture…

Alerts Archive

FDA Seeks Comments on the Content and Format of Substantial Equivalence Reports

Office of Advocacy Apr 12, 2019

On April 2, 2019, the Food and Drug Administration (FDA) published the proposed rule “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence (SE) Reports.” The proposed rule…

FDA: Use of the Names of Dairy Foods in the Labeling of Plant-Based Products

Office of Advocacy Oct 11, 2018

On September 28, 2018, the Food and Drug Administration (FDA) published a request for comments on the labeling of plant-based products with names that include the names of dairy foods such as “milk,” “cultured milk,” “yogurt,” and “cheese.”

Letters to Agencies

Letter to the FDA: Regulation of Premium Cigars, Advance Notice of Proposed Rulemaking

Office of Advocacy Jul 25, 2018

July 25, 2018 On March 26, 2018, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking entitled: Regulation of Premium Cigars. The U.S. Small Business Administration’s Office of Advocacy (Advocacy)…

Alerts Archive

FDA publishes proposed rule on caloric labeling of food products for sale in vending machines

Office of Advocacy Jul 16, 2018

On July 12, 2018, the Food and Drug Administration (FDA) issued a proposed rule titled, Revisions to Certain Requirements for Calorie Labeling on Glass-Front Vending Machines. FDA took this action in response to…

Small Business Losing Patience with New Drug Supply Automation Regulations

Office of Advocacy Mar 6, 2018

By Apollo Fuhriman, Region 10 Advocate In December, I met with Meishelle Haverkamp who works for a local affiliate of Swisslog Healthcare, a company that provides automation solutions for pharmacies, including those in hospitals. In…

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