12
Feb

Skinny Label Reprieve, But Not Out of the Woods Yet!

The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label.  Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case.  Clearly, Congressional intent and regulatory […]

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09
Feb
Complexity Image

Complex Generics and the Prescription Landscape – The Hill Webinar

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 […]

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05
Feb

Safety Trial Finds Increased Risk of Serious Heart-Related Problems and Cancer with Xeljanz, Xeljanz XR (tofacitinib)

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 […]

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02
Feb

Medical Device and Drug Development and Manufacturing Data Governance in the Information Age

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 […]

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01
Feb

Using AI to Modernize Diagnostic Tools

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, […]

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26
Jan

Webinar on FDA Incentives Features Compliance Expert

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 […]

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