Today, The Hill hosted a webinar called “Complex Generics & the Prescription Drug Landscape.” Many thanks to The Hill for their efforts. The takeaway messages from the program participants are important, especially as the current Generic Drug User Fee Amendments III (GDUFA III) negotiations are revving up for the Office of Generic Drugs’ review and […]
When FDA approved the Pfizer drug product tofacitinib (Xeljanz, Xeljanz XR), which treats arthritis and ulcerative colitis by decreasing the activity of the immune system, they required that Pfizer conduct post-approval safety trials to evaluate the risk of serious heart-related events, cancer and infections. Tofacitinib is offered in two strengths which were both studied in […]
We all can see from the OGD metrics that ANDA submissions and approvals have leveled off and have even gone down recently. In the negotiation meetings between FDA and industry for GDUFA III, it seems the Agency recognizes this, but there are some things that don’t seem to make sense and one item that is […]
It is not uncommon for organizations to have different IT systems for regulatory, product, and organizational information. Segregating the data, such as the QMS gate reviews, complaints, and adverse event reporting, from the product sales quota and organizational growth projections and actuals keeps regulatory auditors to the task at hand – inspecting the Quality Management […]
Machine Learning (aka Artificial Intelligence) has put a spotlight on the importance of algorithms. While the term algorithm is ancient, meaning “a process or set of rules to be followed in problem-solving operations,” the modern use within refers to the complex way that the software behaves. Before broad adoption of Machine Learning in other industries, […]
Looks like we all will be doing a lot of reading and assimilation of new information in 2021. The CDER Guidance Agenda – New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021 contains 105 new and revised guidance documents that CDER plans to release this year. While there are a number […]
Next Wednesday’s free webinar from Lachman, “FDA Incentivizing Organizational Maturity to Drive Product Quality,” will be hosted by Lachman’s Vizma Carver, M.S. In this 90-minute session, she will dive in on the FDAs efforts to utilize incentives to drive product quality. As someone who used to work at the FDA, Ms. Carver is uniquely positioned […]
The FDA is focused on evolving the medical device industry, ensuring safety, and enhancing quality among all manufacturers. Their goals are being met in part through two incentive programs – the Center for Devices and Radiological Health’s (CDRH) Case for Quality Voluntary Improvement Program (CFQ VIP) and the Center for Drug and Evaluation Research’s (CDER) […]
So, here is my question – when will the Congress and the FDA get off their butts and do something about active pharmaceutical ingredients appearing in dietary supplements or the other issues with dietary supplements that occur over and over? This is not a new problem. We have posted about it numerous times here, here, […]
While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed. The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, […]
