<span class="archive__title-prefix>Posts Categorized:</span> Blog

Note: The data provided in this post was gathered in July 2023. Compared to other global health agencies, the FDA is the most open and transparent with its data via the FDA Data Dashboard and the Freedom of Information Act (FOIA). There are some significant limitations to the FDA Data Dashboard, however. The number and […]

This article covers additional questions submitted from the webinar, Legal Considerations | Interacting with the FDA Before, During, and After Inspections, presented by FDA Law Partner Neil DiSpirito. In the webinar, Neil discussed the legal concept of the FDA inspection as a Warrantless Search. Removing the 4th and 5th Amendments’ due process clauses in gathering […]

What are some of the product and regulatory challenges companies developing cell and gene therapy (CGT) products may face during late-stage development? At the ISPE Annual Meeting held in Orlando, Florida, in early November, Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) Division of Cellular and Gene Therapies Branch […]

“I want to talk about the warrantless search, and that’s really what an FDA inspection is,” says Neil DiSpirito, kicking off his new webinar with Redica Systems earlier this month. “They don’t have to Mirandize you,” he says. “They don’t have to have a search warrant. You’re pervasively and extensively regulated.” It’s a little provocative, […]

In Part 1 of this article, we explored FDA’s policy on reviewing internal audit reports as outlined in Compliance Program Guidance (CPG) Sec. 130.300, FDA Access to Results of Quality Assurance Program Audits and Inspections, which clearly states that the agency will not review internal audit reports other than in exceptional circumstances as listed in […]

On July 10, 2023, China’s Center for Drug Evaluation released a draft guidance for a two-week comment period titled, “Safety Information Assessment and Risk Management Work Procedures.” It outlines the agency’s expectations for the monitoring, identification, evaluation, control, and communication of safety risks during clinical trials conducted in China. According to the public notice, the […]

FDA Site Selection Model Updated to Include Regional Risk Factors A late-June 2023 update to FDA’s MAPP 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” adds new factors to how the agency selects which sites to inspect, most importantly, the general compliance history in the country or region where the company under consideration is located. […]

Key point summary: In the June 2023 FDA Report, “Fiscal Year 2022 Report on the State of Pharmaceutical Quality,” from a GMP inspection and compliance perspective, of particular interest are that FDA conducted three times as many surveillance inspections in 2022 as compared to the 115 conducted in 2021, which included 129 inspection classifications under […]

A fundamental tenet for drug product development is that a clear and deep understanding of the product is required to appropriately develop and characterize it. Exploring product attributes early in development will facilitate identifying which critical quality attributes (CQAs) to focus on in later clinical phases. At the ISPE Annual Meeting held in Orlando, Florida, […]

Outsourcing and/or manufacturing of Active Pharmaceutical Ingredients (APIs) can present many challenges, whether it’s staying up to date with agency regulations, monitoring suppliers, or preparing for inspections by the U.S. FDA. While the facilities and processes for producing APIs must meet the principles of GMP in the FD&C Act, only finished dosage forms are subject […]