Kathleen Sanzo on Food and Drug Administration (FDA)

Reassessing Drug Inspection Targets: FDA Updates Internal Policy for Risk-Based Site Selection Model

In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy)....more

7/11/2023 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Pharmaceutical Industry , Prescription Drugs

Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods

FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more

6/14/2023 / Comment Period , Dietary Guidelines , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Proposed Rules , Regulatory Agenda , Regulatory Reform

A Sweet Deal: FDA Allows New Qualified Heart-Healthy Claim for High Flavanol Cocoa Powder

FDA recently announced it does not object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular...more

5/2/2023 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , Health Claims , Nutrition Facts Labels , Regulatory Agenda

Fifth Circuit Mifepristone Pile-on Decision: A Judicial Double Attack on FDA

While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still...more

4/18/2023 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry

FDA Issues Final Guidance on Quality Considerations for Clinical Research on Cannabis and Related Compounds in Drugs

The US Food and Drug Administration (FDA) recently issued a final guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” The guidance finalizes a 2020 draft guidance outlining how...more

2/20/2023 / Cannabis Products , Final Guidance , Food & Drug Regulations , Food and Drug Administration (FDA) , Marijuana , Medical Marijuana , Scientific Research

No Love for Accelerated Approval Drugs: CMS Announces Valentine's Day Model to Decrease Payments for Accelerated Approval Products

The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway before a clinical benefit has been...more

2/16/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Prescription Drugs

The Trends—and Traps—that Will Shape 2023

The last few years have thrown many surprises at businesses. Organizations across all sectors have faced inflation, global conflicts, supply chain challenges, a pandemic, and continually changing government policies. In 2023,...more

1/23/2023 / Automotive Industry , Capital Markets , Cryptocurrency , Energy Sector , EU , False Claims Act (FCA) , FDIC , Financial Services Industry , FinTech , Food and Drug Administration (FDA) , Life Sciences , Tax Credits

FDA Embraces Alternative Tools for Inspecting Facilities

On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and...more

10/21/2022 / Food and Drug Administration (FDA) , Inspections , Manufacturers , Manufacturing Facilities , Pharmaceutical Industry , Risk Management

Eat Your Greens: FDA Proposes New Definition for ‘Healthy’ Packaged Food Claims

The US Food and Drug Administration issued a proposed rule on September 29 setting forth new criteria for the labeling of food products with the nutrient content claim “healthy” intended to help consumers more easily navigate...more

9/30/2022 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , Food Safety , Health Claims , Nutrition Facts Labels , Regulatory Agenda

Executive Order Outlines New Federal Biotechnology/Manufacturing Goals

President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this EO, the president aims to...more

9/19/2022 / Biologics , Biotechnology , Executive Orders , Food and Drug Administration (FDA) , Life Sciences , Medical Research , Research and Development

FDA Outlines Evaluation Approach to Non-Major Food Allergens in Draft Guidance

Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk,...more

4/27/2022 / Draft Guidance , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , Nutrition Facts Labels

Dr. Robert Califf Confirmed to Fill FDA Commissioner Position

The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more

2/16/2022 / Administrative Appointments , Biden Administration , Coronavirus/COVID-19 , FDA Commissioner , Food and Drug Administration (FDA) , Opioid , Pharmaceutical Industry , Regulatory Agenda

Monograph Soup: The ABCs & XYZs for OTCs on Formal Meetings with FDA

The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more

2/15/2022 / Administrative Orders , CARES Act , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC) , Pharmaceutical Industry

FDA Grants First E‑Cigarette PMTA Authorization

The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more

11/11/2021 / E-Cigarettes , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Premarket Approval Applications , RJ Reynolds , Tobacco , Tobacco Regulations , Vaping

A Pinch of Salt, but No Pepper(ing) This Time: FDA Issues Voluntary Guidance on Sodium Reduction

FDA issued a Voluntary Sodium Reduction guidance in October 2021, aimed to help Americans reduce average daily sodium intake over the next two and a half years. The guidance suggests voluntary sodium reduction targets for...more

11/4/2021 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , Nutrition Facts Labels , Public Health , Regulatory Requirements

New US Department of Agriculture Initiative to Combat Salmonella in Poultry

The US Department of Agriculture (USDA) recently announced a new initiative that its Food Safety and Inspection Service (FSIS) plans to put in place to limit Salmonella in poultry plants to help reduce related illnesses....more

10/27/2021 / Food and Drug Administration (FDA) , Food Contamination , Food Safety , Food Safety and Inspection Service (FSIS) , Food Supply , Poultry , Salmonella , USDA

Anti-Spoil(er) Alert: FDA Issues Guidance on Antimicrobial Agents in Food

FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more

10/13/2021 / Antimicrobials , Environmental Protection Agency (EPA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Safety , Life Sciences , Memorandum of Understanding , Public Health , USDA

FDA Signs Domestic Mutual Reliance Agreements with Four States to Protect Food Supply

FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to...more

10/13/2021 / Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Life Sciences , Regulatory Oversight

Food Labeling Modernization Act Reintroduced in Congress

Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary...more

9/15/2021 / Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Importers , Interstate Commerce , Labeling , Proposed Amendments

USDA’s Proposal to Take Back Regulatory Oversight of GM Animals from FDA Remains Viable Despite Change in Administration

On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A...more

6/23/2021 / Advanced Notice of Proposed Rulemaking (ANPRM) , Biotechnology , Federal Meat Inspection Act (FMIA) , Food and Drug Administration (FDA) , Food Safety , Genetically Engineered Animals , Memorandum of Understanding , Poultry Products Inspection Act (PPIA). , Proposed Rules , Regulatory Oversight , USDA

Bipartisan Group of Senators Introduces Bill to Regulate Hemp and Hemp-Derived CBD in Food

US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other...more

6/2/2021 / Beverage Manufacturers , Cannabidiol (CBD) oil , Cannabis Products , Dietary Supplements , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Health and Safety , Legislative Agendas , Marijuana , Plant Based Products , Regulatory Agenda , Regulatory Oversight

5/11/2021 / Biden Administration , Disclosure Requirements , Federal Food Drug and Cosmetic Act (FFDCA) , Food Allergies , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , New Legislation , Public Health , Retail Market

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