05
Jul
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OGD Updates the Other May 2022 Statistics

On July 1, OGD updated its monthly statistical report for May 2022 (here). The additional stats (while not particularly remarkable) outline the workload output for the ANDA review and approval process and should be of interest to most of us that pay attention to OGD output. Highlights of the final May statistical report appear below. […]

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05
Jul

How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

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01
Jul

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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30
Jun

How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]

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28
Jun

Looking for ANDA Candidates with No Generic Competition?

The FDA recently published an updated version of the Current List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (here).  The list is broken down into two parts that identify either prescription or over‑the‑counter drugs (that require an ANDA as the subject of approval), and each of these respective lists is broken down into two […]

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21
Jun

Official Approval Numbers for May 2022 and Update on April Stats

Well, just like that, OGD posted the official approval actions along with some other metrics for May and also updated the rest of the April statistics.  We have been touting the May approval action and we were ever-so-close but missed by one. The actual official May approval actions are as follows: Full approval actions 84 […]

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16
Jun
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A Peek at Mid-Month June 2022 Approval Actions

June looks fairly strong but likely not as strong as May’s projected unofficial total (ninety‑three full and tentative actions).  With postings through June 14th on the FDA’s Daily and All Approval lists (here and here), as of 10:30 a.m. on June 16, 2022, there were twenty‑three full‑approval actions and nine tentative‑approval actions.  This total of […]

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16
Jun

Engaging with FDA: Hidden Gems at the FDLI Annual Conference Day 1

The first day of the Food and Drug Law Institute’s Annual Conference started with an excellent keynote address from FDA Commissioner Dr. Robert Califf, who underscored the importance of the FDA engaging with industry to evaluate the promise (as well as risks) of new technology and medicinal products.  Part of that dialogue happens at the individual […]

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