The Lachman Blog

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24
Aug

“Proper” Was Not Proper in Guidance

Today, FDA reissued the Guidance for Industry: Abbreviated New Drug Application Submissions-Refuse to Receive for Lack of Justification of Impurity Limits, but the word “Proper” was removed from its title.  The title of the previous version read Abbreviated New Drug Application Submissions- -Refuse to Receive for Lack of Proper Justification of Impurity Limits (emphasis added). While […]

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23
Aug

Fidaxomicin BE Recommendations Consistent with FDA’s Vancomycin BE Recommendations-Almost!

  Fidaxomicin, like vancomycin, is indicated for treatment of Clostridium difficile-associated diarrhea.  Both drugs are poorly absorbed systemically and treat the condition locally in the gut and intestines. Vancomycin, however, appears to be more soluble that fidaxomicin over the range of physiologically-relevant dissolution media.  The innovator of fidaxomicin submitted a petition, FDA-2015-P-1595 (here) requesting that […]

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21
Aug

The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

An article authored by Jim Davidson, Ph.D, Vice President, recently appeared in the July-August issue of Pharmaceutical Engineering. This very timely article, “The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing”, has also been the subject of White Papers authored by LCS, as well as the topic of numerous industry symposia. Congrats to Jim […]

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19
Aug

So How Many ANDAs and 505(b)(2) NDAs Have Had Approval Delayed by Petitions in 2015?

For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications.  Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Administration Act [FDAAA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs, […]

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18
Aug

Follow-up on PIC/S Data Integrity Guidance

We recently posted an overall summary of the new draft PIC/S Data Integrity Guidance document (here). While this valuable Guidance document covers much of the same ground as previous Data Integrity Guidance documents from other regulatory agencies, it is particularly noteworthy that in several areas it provides detailed practical requirements heretofore never provided in a […]

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15
Aug

PIC/S Draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments”

 It is critical during the inspection process that FDA inspectors can determine the veracity of the data that is presented to them. The draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” dated August 10, 2016, provides inspectors detailed instructions on how to verify the integrity of the data during inspection […]

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