The Lachman Blog

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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11
Feb

LACHMAN’S MEDICAL DEVICE WEEK REVISITED

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 […]

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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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05
Feb

Cybersecurity Must Be Offensively Proactive to Protect Your Assets

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 […]

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04
Feb

Don’t Reinvent the Wheel – Use Your SDLC Infrastructure to Manage Product Change Control

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 […]

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02
Feb

No New FDA FR Notices Since the Inauguration!

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 […]

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