Science & Technology

08
Oct
Female chemist adds drops of blue substance into test tubes, lab research

How Current is Your Stability Program?

A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing.  During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing. Neither the current guidance ICH Q1A(R2) “Stability Testing of New […]

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01
Oct
Close-up of unrecognizable laboratory worker viewing statistical data while analyzing result of DNA test

The Importance of Trending During Laboratory Investigations

It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action.  However, what can get overlooked during the investigation process is the importance of trending.  This is a key component of root cause confirmation, assessing the appropriateness […]

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16
Sep
Yellow warning sign screwed to a brick wall to warn about a threat. In the middle of the panel, there…

FDA Is Eliminating Regulations? Here’s One that Makes Sense!

The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA.  The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777.  Under these EOs, FDA is comprehensively reviewing existing regulations to identify […]

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13
Sep
Female chemist at work in laboratory.

Reduced Testing, but Not Reduced Expectations

Reduced testing of Active Pharmaceutical Ingredients (API), excipients, and other raw materials can be a valid approach to gaining overall efficiencies in the pharmaceutical quality control laboratory.  However, the choice of tests to perform and the justification for choosing those tests are key elements of operating a compliant Reduced Testing Program that is also scientifically […]

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11
Sep

Where There is Smoke, There is Fire!

The FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER), gave a presentation on April 12, 2016 entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.”  A key take-away from the presentation was that the Agency supports the development of drugs derived from marijuana (MJ).  This included […]

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10
Sep
Action shot of a cowboy riding a horse

Changes to Drug Substance Draft Guidance Come to Town!

The GDUFA II reauthorization process involved a lot of agreements from the FDA.  One of those agreements was for the Agency to publish a guidance on changes to drug substances that addressed the type of changes, their categories for submission (PAS, CBE, CBE-30, or annual report) and the necessary documentation that must be submitted to […]

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07
Sep

Awareness And Precision Are Key To Manufacturing Data Integrity

The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory. The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the […]

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27
Aug

Nominations to FDA Bulk Drug List for 503B Compounders Provides Three Strikes

In yesterday’s Federal Register (FR) prepublication page, the FDA described three drugs that were nominated for inclusion on the bulk list but all three were declined for the same basic reason. Inclusion on the bulk list would have provided 503B-registered compounding facilities with the ability to utilize the substances in bulk in order to prepare […]

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21
Aug

Chew on This!

Today, the FDA finalized a draft guidance that issued on June 16, 2016 titled Quality Attribute Considerations for Chewable Tablets (here).  The document provides advice to sponsors of NDAs, ANDAs, some chemistry supplements, INDs, and manufacturers of non-application chewable products on the critical attributes that should be identified and quantified for chewable immediate release tablets. […]

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12
Aug

Biosimilars and Complex Generics Uptake Not as Expected – Why is that a Surprise?

Many articles had decried the fact that biosimilar uptake is not what FDA or the drug industry anticipated.  Look, I have been around in this industry in one form or another (pharmacist, regulator, and consultant) for 46 years and have seen a lot in my day.  They say history repeats itself – no I am […]

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