New Drugs


How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

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Is Help on the Way? Contrast Agents and Drug Device Conundrum May Be Legislated Away

In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal.  This court decision dealt with […]

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New Dissolution Method for Long-Acting Injectable Suspensions May Provide Better Data

FDA and industry have long wrestled with appropriate dissolution methodology for injectable suspension products. Investigations into the relevance of the dissolution methods utilized has shown wide variation in in vivo results despite consistent in vitro performance. As FDA notes in a recent article (here) on the new potential improved method developed to address “gaps between […]

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Pilot Program for Novel Excipients Announced

The use of novel excipients has potential to assist in the development of better final drug-product formulations for patients.  However, drug-product manufacturers are hesitant to use novel excipients in product development because of the uncertainty of the expectations of the FDA and, ultimately, on the FDA’s acceptance of the new excipients in its development program. […]

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Benzodiazepines in the Crosshairs?

In previous blogs (here, here, here, and here), we discussed abuse-deterrent formulations and the potential “creep” in applying this approach towards substances other than opioids.  So far, we have not seen a big move in that direction, most likely because of the lack of any great success of currently approved abuse-deterrent formulations from actually preventing […]

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Sockeye Salmon Jumping Up Falls

Between a Rock and a Hard Place – Accelerated Approval for Alzheimer’s Drug Brings Cheers and Jeers!

Three FDA Advisory Committee members resigned over the FDA’s decision to grant accelerated approval to aducanumab for treating Alzheimer’s Disease.  One member said, when he resigned, that “this is the worst decision the FDA has ever made.”  I get it.  When the entire committee voted against approval (full approval), the FDA kind of backdoored its […]

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