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 […]
Medical Device Week, a Lachman Learning Experience™ provided a great opportunity for industry professionals to gain knowledge and insight into a range of topics critical to the medical device industry. Our initial feedback indicates that those who participated found it valuable and highly informative. One of the most important topics covered was the FDA’s focus […]
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 […]
Interoperability in healthcare has been discussed for decades and is one the greatest challenges to be overcome in medicine. Not only because technical barriers exist, but because physicians practice medicine and research continue to push the boundaries, creating new terms to be defined and understood. In addition, the rate of this is accelerating (witness the […]
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 […]
As you know, we try to track the ANDA approval actions and report on other OGD metrics as closely and as early as we can to try to give you the most current and most timely information. The one thing we have found that the generic industry, as a whole, is most interested in are […]
What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA? I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]
We know that a regulation hold has been placed by the Biden Administration until they can review their positions on proposed regulations, but it is highly unusual that no FR notices have appeared since Inauguration Day, January 20, 2021. Many FR notices address issues other than regulations, including meeting notices, guidance announcements, collections of information […]
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 […]
