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A new draft guidance titled (quite originally) Drug Master Files (here) has replaced the Drug Master Files: Guidelines that was published in 1989.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 […]
In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community. The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first […]
In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here). Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for […]
CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here). The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise. The FDA says, “the changes increase the number of OND offices that oversee our review divisions from […]
Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]). The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints. Ms. […]
