What the Future May Hold for Pharma Regulation Under the Biden Administration
Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among...
View ArticleFDA Places Mexican-Made Hand Sanitizers on Import Alert Due to Toxin Risks
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential...
View ArticleVaccine Development and Distribution: Legal Considerations for US Healthcare...
As the United States races to deliver safe and effective coronavirus (COVID-19) vaccines under the Biden administration, employers, healthcare providers, and many others are assessing what it means for...
View ArticleFDA Issues More Guidance on Gene and Cell Therapy Products
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic...
View ArticleSesame Becomes Newest Major Food Allergen
US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal...
View ArticleHeme-Burgers and Hot Dogs: Ninth Circuit Affirms FDA’s Approval of Plant Meat...
A US Court of Appeals for the Ninth Circuit panel recently affirmed a decision by the US Food and Drug Administration (FDA) approving soy leghemoglobin (also known as “heme”), a soy protein ......By:
View ArticleFDA’s Latest Initiatives Seek Input from Industry to Develop Food...
To enhance its food traceability objective through the use of technology that strengthens the food safety system, the US Food and Drug Administration (FDA) unveiled, on May 19, its latest initiative...
View ArticleChocolate Cicadas and Mealworm Mints: Will FDA Spit Out Guidance for Edible...
The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....By:
View ArticleBipartisan Group of Senators Introduces Bill to Regulate Hemp and...
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...
View ArticleUSDA’s Proposal to Take Back Regulatory Oversight of GM Animals from FDA...
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...
View ArticleFTC and USDA Promote Transparency in ‘Made in USA’ Labeling Claims
The Federal Trade Commission (FTC) recently issued a final rule that marks a major shift in the regulatory landscape for labeling that has already begun to impact other regulatory bodies—namely, the US...
View ArticleProposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant...
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of...
View ArticleFood 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...
View ArticleUSDA Bioengineered Food Disclosure Rule Goes Into Effect on January 1, 2022
The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS)....
View ArticleFDA Signs Domestic Mutual Reliance Agreements with Four States to Protect...
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...
View ArticleAnti-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...
View ArticleNew 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...
View ArticleA Pinch of Salt, but No Pepper(ing) This Time: FDA Issues Voluntary Guidance...
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...
View ArticleFDA 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...
View ArticleMonograph 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...
View ArticleDr. 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...
View ArticleFDA 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...
View ArticleExecutive 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...
View ArticleEat 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...
View ArticleFDA 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...
View ArticleCPSC to Industry: Get Ready for More – More Penalties, More Litigation, More...
The US Consumer Product Safety Commission (CPSC) will take a hard and fast approach to product safety in FY23, according to its recently passed operating plan, with enforcement being at the top of its...
View ArticleThe 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...
View ArticleNo Love for Accelerated Approval Drugs CMS Announces Valentines Day Model to...
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...
View ArticleFDA Issues Final Guidance on Quality Considerations for Clinical Research on...
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...
View ArticleFifth 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...
View ArticleA Sweet Deal: FDA Allows New Qualified Heart-Healthy Claim for High Flavanol...
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...
View ArticleSalt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in...
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...
View ArticleReassessing Drug Inspection Targets: FDA Updates Internal Policy for...
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...
View ArticleHigh-Tech Revamp: FDA Announces New Measures for Clinical Trials, Invites...
FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft...
View ArticleFeatherless Revolution: FDA and USDA's Approval of Cell-Cultivated Chicken...
In a historic decision, the United States Department of Agriculture (USDA) has approved two companies, Upside Foods and GOOD Meat, to market lab-grown chicken in the United States....By:
View ArticleA New Foundation: FDA Issues Draft Guidance On Mocra Cosmetic Registration,...
The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product...
View ArticleCombining the ‘Ingredients’: FDA Reorganizes Human Foods Infrastructure Under...
In a sizable step toward reorganizing the Human Foods Program (HFP or Program) to rehaul the US Food and Drug Administration’s (FDA’s) current food infrastructure to better coordinate the agency’s...
View ArticleBetter Late Than Never: FDA Issues Long-Awaited Final Informed Consent Guidance
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent...
View ArticleFDA’s Orange Book Listing Process: FTC Formally Joins the Fray
The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book...
View Article2023 Drugs and Biologics Year in Review: Will FDA's 2023 Evolution Usher in...
The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to...
View ArticleUS Supreme Court Hears Oral Arguments in Challenge to Chevron Deference
The US Supreme Court recently debated the future of the legal precedent known as Chevron deference in two separate cases arising out of the National Marine Fisheries Service’s statutory interpretation...
View ArticleYogurt and Type Two Diabetes: FDA Serves Up New Qualified Health Claim
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and...
View ArticleFDA Releases Guidance on Data Monitoring Committees for Clinical Trial...
The US Food and Drug Administration (FDA) recently issued draft guidance with recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be beneficial for...
View ArticleThat’s a Wrap: FDA Announces Phase-Out of PFAS in Certain Food-Packaging...
The US Food and Drug Administration (FDA) recently announced that manufacturers have completed the voluntarily phase-out of the use of certain per- and polyfluoroalkyl substances (PFAS) in...
View ArticleFrom Prohibition to Prescription: DEA Issues Proposed Rule to Reschedule...
On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled...
View ArticleLife Sciences Post-Chevron: Navigating the Range of Legal and Regulatory...
The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer...
View ArticleFDA Issues Guidance on Foods Made from Genome-Edited Plants in Newest Update...
The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for...
View ArticleThe Horse Is Out of the Barn: FDA and AAFCO Memo of Understanding on Animal...
The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing...
View ArticleFood Safety 3.0: FDA Implements Human Foods Program Alongside Long-Awaited...
On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP...
View ArticleHow the US Election May Affect the FDA Regulation of Life Sciences Products –...
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question...
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