CPSC 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FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP).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 Article