The Lachman Blog

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22
Sep

Self-Identification Guidance for Generic Facilities Issued by FDA

Under the Generic Drug User Fee Amendments (GDUFA) of 2012, all generic facilities, sites and organizations are required to comply with the self-identification requirements of the GDUFA.  This Guidance document is intended to facilitate firms’ understanding of the requirements, and thus, make self-identification easier to accomplish.  The document also discusses which of the facilities, sites, […]

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21
Sep

Women in Pharma Debuts at 2016 ISPE Annual Meeting & Expo

ISPE presented the first in a series of planned annual events entitled, “The Women in Pharma” on Monday 19 September at its 2016 Annual Meeting. Key female pharmaceutical industry executives shared their stories at the morning session, focusing on the challenges and opportunities each embraced as they progressed though their careers. The session was led […]

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20
Sep

Perhaps Thinking of Someone’s Similar Name? New MaPP May help Avoid Disappointment

Often times proposed proprietary names go down to the approval wire, and sometimes there is last minute disappointment on behalf of at least one of the sponsors.  For instance, when a proprietary name is cleared during the IND, NDA, or ANDA review, in the period between clearance and approval, there may be another applicant that […]

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16
Sep

Data Governance – Establishing a Path Forward to Assure Data Integrity

Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety.  Companies are in a frenzy responding to regulatory citations and preparing for inspections.  The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated […]

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13
Sep

Court Reverses Itself on NCE Issue-What Happens to ANDAs Already Received?

In a stunning reversal of opinion on the issue of FDA’s failure to award new chemical entity (NCE) exclusivity to the drug Prepopik, the world of NCE awards and ANDA acceptance for receipt for fixed dose combination (FDC) products that contain a first-time approved active ingredient may be turned on its head.  This was discussed […]

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12
Sep

FDA Updates List of Guidance Documents It Plans to Issue in 2016

The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016.  We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents.  Well, FDA has published another revised list and here are the changes: Comparative […]

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