The European Commission’s newly released draft guidelines (May 2026) on high-risk AI systems mark a pivotal step in operationalizing the EU AI Act. While the Act itself established a risk-based regulatory framework back in 2024, these guidelines provide much-needed clarity on how to determine whether an AI system falls into the “high-risk” category—arguably the most […]
The commercial landscape for GLP-1 products is very different than for other pharmaceutical products. Demand is extremely high given the prevalence of obesity, direct-to-patient sales through social media and other channels, and public interest magnified by celebrity endorsement. When these factors overlap, pharmacovigilance (PV) activity increases quickly—and not always in predictable ways. These products are […]
The Coming Wave of GLP-1 Competition The global success of GLP-1s has reshaped the metabolic disease landscape, driving unprecedented demand across diabetes, obesity, and adjacent indications. As key patents for leading products (such as semaglutide and tirzepatide) approach expiration in various countries, a new wave of companies, ranging from traditional generics manufacturers to complex peptide […]
In today’s pharmaceutical environment, remediation following FDA enforcement action has become more complex, data-driven, and scrutinized than ever before. Recent trends, including a holistic view and an increased focus on data integrity, digital system validation, supply chain oversight, and quality culture, have raised the bar for what constitutes an effective and sustainable remediation program. Companies […]
What began as a concept previewed earlier this year has now become official policy. Today, the U.S. Food and Drug Administration (FDA) announced the launch of its “One-Day Inspectional Assessments” program, formalizing a new inspection model aimed at certain low-risk facilities (here). Under the initiative, qualifying sites may undergo a streamlined, single-day inspectional assessment while […]
While cosmetics have been included in the Federal Food, Drug, and Cosmetics (FD&C) Act since its passage in 1938, the Agency saw limited expansion of its authority between 1938 and 2022. However, with the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, that all changed. MoCRA gave new authority […]
Today, the FDA published a Federal Register (FR) notice (here) announcing a preliminary decision regarding three bulk drug substances that it “has evaluated and is proposing not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide.” The notice further states that the FDA will consider comments submitted to the docket until June 30, 2026 […]
On April 29, 2026, the FDA published a notice in the Federal Register (FR) (posted on the FR prepublication page (here)) announcing the FDA’s intention to withdraw approval of the New Drug Application (NDA) for TAVNEOS (avacopan) capsule, 10 milligrams (mg), held by ChemoCentryx, Inc. and offer the applicant an Opportunity for a Hearing regarding the FDA’s […]
This month, April 2026, the Center for Drugs Evaluation and Research’s (CDER’s) Office of Compliance (OC) issued its yearly report, highlighting many of its goals, new programs, and accomplishments. First, let’s take a look at the report by the numbers. According to the report (here), the OC lists the following workload figures: Office of Compliance […]
The second day of the Generic Drugs Forum provided a significant amount of new and rehashed data, including explanations and suggestions regarding certain application submission issues, including but certainly not limited to DMFs, data integrity and the ongoing nitrosamine saga. Here are a few of the helpful hints presented: When providing amendments to DMF, the […]
