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FDA published a revised draft guidance titled Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.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 […]
A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989. There have been many changes to the requirements and procedures for DMFs based on new laws, policies, and procedures, as well as procedures associated with GDUFA commitment letters for ANDAs, and (of […]
It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program. The Federal Register Notice (here) announcing the availability of the […]
[vc_row][vc_column css=”.vc_custom_1570720331401{margin-bottom: 20px !important;}”][vc_column_text]Aloka Srinivasan, Vice President, Regulatory Practice at Lachman Consultants recently wrote an article for PharmTech, detailing the Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development. The article provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in […]
The use of alternate methods, especially for USP methods, some of which are rather old, has long been a question that both the industry and the FDA have contemplated. Alternate methods can be easier to use and, in some instances, more accurate and reliable. But how can you demonstrate that an alternate method is indeed […]
In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory. The FDA takes refusal of inspection very seriously and the impact […]
