Get Ready for a New Approach to cGMP Inspections

Earlier this week, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here).  Although the Draft is still out for comments, it gives us a behind-the-scenes look at the FDA’s use of proposed “alternative tools” in conducting remote-based inspections.  The proposed Guidance […]

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Regulatory Due Diligence for Drugs – Hidden Surprises?

Many companies are always on the lookout for in‑licensing opportunities and/or product acquisitions to boost their product portfolio or to quickly fill voids in their development program.  Given the cost outlay for such opportunities and their associated risks, it is imperative that due diligence of these new potential assets is performed by qualified individuals who […]

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Top Risks of the 510(k) Premarket Notification Process

As with any regulatory submission, there are inherent risks associated with the submission and approval process if required data are incomplete or missing.  In addition, compliance activities can play a major role in risks following approval and with commercialization of products. Some of the risks specific to 510(k)‑cleared devices include: Submission Rejection/Approvals: FDA 510(k) submissions […]

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Biosimilar Interchangeability: The Need to Reconsider?

Introduction On November 17, 2022, Sen. Mike Lee (R-UT) introduced a Bill entitled the “Biosimilar Red Tape Elimination Act” with the intent to increase competition within the US biosimilar market and reduce consumer costs associated their development.  The Bill proposes to eliminate the interchangeability requirement of conducting switching studies associated with biosimilar drug development. In […]

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