The Lachman Blog

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10
Jan

Good News/Not So Good News? Compounding and Repackaging of Radiopharmaceuticals

FDA issued two new Guidance for Industry Documents late in 2016: (1) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here) and (2) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (here).  These represent the 25th and 26th  draft and/or final Guidances issued by FDA relating to pharmacy compounding.  More will […]

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09
Jan
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

FDA Issues Three New Guidances for Compounding Pharmacies on December 28, 2016

FDA issued three new Guidance for Industry Documents late in 2016: (1) Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here) ; (2) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here); and (3) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing facilities (here). These represent part […]

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05
Jan

Botanical Drug Development Guidance Undergoes Its First Revision

First issued in draft in 2004 and then revised as a draft in 2015, Revision 1 of the Guidance document “Botanical Drug Development” issues in final form. The Guidance reflects current Agency thinking on the drug development process for new drugs (NDAs), investigational new drug applications (INDs) to support NDAs, and a discussion of the […]

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04
Jan

November 2016 OGD Stats Updated

OGD posted additional statistics relative to metrics that it routinely tracks by month.  Included in these numbers are data on Refuse-to-Receive (RTR) actions, supplements received, controlled correspondence, etc. All of FY 2016 monthly RTR actions were in the double digits except for September, which saw only 9 RTR actions.  Well, 2017 seems to be starting […]

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03
Jan

More Bioequivalence Guidance Documents Issued by OGD

The Office of Generic Drugs (OGD) has been busy in the bioequivalence arena as evidenced by its issuing of 31 new recommendations and revising 17 previously issued recommendations.  The list of new and revised recommendations can be found here. As always, there are some specific recommendations that are of note while others are standard bioequivalence […]

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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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