Today’s prepublication of the Federal Register contains the proposed rule for drug importation from Canada. The proposed rule is 172 pages long and outlines the FDA expectations for the safe importation of drug products from Canada. Section 804 Importation Programs (SIPs) provides the basis for each request for importation and provides the importation requirements. The […]
N-Nitrosodimethylamine (NDMA), which was previously found in angiotensin II receptor blockers (the ‘sartans”), which are blood pressure medications, and more recently, in ranitidine (a heartburn medication) has caused nationwide recalls of the products. Now there is a hint that metformin, a widely used drug for diabetes, may be implicated as well, as Singapore’s Health Sciences […]
Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect. A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”. Since the beginning of time, the Agency […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
In a prepublication of the Federal Register today, the FDA announced its intentions to withdraw four NDAs (see chart below) for failure to submit required annual reports. In the notice, the Agency noted the firms have been contacted by the Agency but have repeatedly failed to submit the required reports. The Notice provides the firms […]
Dr. Scott Gottlieb is back in the private sector and took the time to give the attendees at the AAM conference a brief overview of his experience as Commissioner. Dr. Gottlieb spoke about the creation of the Competition Action Plan which addressed action on the following issues: Gaming the system through REMS and restricted distribution […]
Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem. Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy. There has even been one firm created […]
I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks (here). The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no […]
FDA published a revised draft guidance titled Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry. If you have any post approval study requirements for any of your products, you should pay close attention to this document. In describing the document, the Agency says: “This […]
The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc. The document provides specific guidance on what, where, and how to list such […]
