22
Dec

Michael L. Keech, M.B.A. New Head of Business Strategy at Lachman Consultant Services, Inc.

We are pleased to announce that Michael Keech will join Lachman Consultants as Head of Business Strategy, effective January 3, 2017. Mr. Keech comes to Lachman Consultants as a seasoned Quality, Compliance and Manufacturing professional who has worked in the Life Sciences field for over 25 years. Mr. Keech has helped global corporations transform into […]

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22
Dec

Linda Evans O’Connor, M.B.A. Promoted to Head of Business Processes and Regulatory at Lachman Consultant Services, Inc.

We are pleased to announce that Linda Evans O’Connor, M.B.A. has been promoted to Head of Business Processes and Regulatory at Lachman Consultant Services, Inc. Ms. Evans O’Connor will continue in her recognized leadership role as part of the Compliance Practice and will oversee the administrative activities of the Regulatory Department as well as support […]

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19
Dec

Boxed Warning for Serious Mental Health Issues Removed from Chantix and Zyban Labeling

Back in April 2016, we posted a blog regarding the potential for the FDA to remove the Black Box warning on two products indicated to help patients stop smoking based on a large clinical study that the FDA required.  At that time when the studies were submitted, the Agency indicated it would review the results […]

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15
Dec
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

FDA Publishes List of First Bulk Drug Substances for 503A Compounding

The FDA issued a Proposed Rule (here) that announced the first additional 6 bulk drug substances for inclusion on the listing of bulk drug substances acceptable for pharmacy compounding, although they are neither the subject of an applicable United States Pharmacopoeia (USP), nor National Formulary (NF) monograph, nor components of FDA-approved drugs. Specifically, the Agency […]

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08
Dec

Ready, Set, Go! Program Fee Cleanup List Now Available -Timeline Outlined

  On November 21, 2016 we issued an important alert (here) relative to the FDA activities regarding the proposed GDUFA II Program Fees and the responsibility of industry to review the list and provide feedback to FDA relative to its accuracy and whether there was an affiliate relationship among entities listed.  This so-called “cleanup” activity […]

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