Regulatory Affairs

01
Jul

Continuous Manufacturing vs. Batch Manufacturing – Where Will the Industry Go?

In a recently released publication on the FDA website entitled, An FDA Self-Audit of Continuous Manufacturing for Drug Products (here) the FDA relayed its experience with some quantified data and some estimates of savings from the use of the continuous manufacturing (CM) vs. batch manufacturing (BM) albeit, from a limited number of applications. Key take […]

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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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29
Jun

Rescinding Breakthrough Therapy Designation – Guidance Provides FDA’s Thinking

The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.”  The program is designed to “facilitate and expedite” review of promising […]

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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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23
Jun

Beta‑Lactam Antibiotics 2013 Guidance for Preventing Cross Contamination Hits the Street

The focus on beta‑lactam antibiotics has primarily concentrated on penicillin and its derivatives because of the issue of severe allergy or anaphylaxis that can occur in individuals with sensitivities to these products.  Over the years, as more and more non‑beta‑lactam antibiotics were introduced to the market, there has also been growing concern that these new […]

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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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14
Jun
Young man looks at road map near on mountain road, Switzerland

To Measure or Not to Measure, Quality Metrics Is the Question!

The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion.  People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation.  Thus, quality metrics were held tightly close to the chest of business leaders.  Deming identified this […]

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