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Latest Blogs

FDA Issues Guidance Document on CGT

Today, the FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” which describes the new statutory requirements under section 506H of the FDA Reauthorization Act of 2017 (FDARA).  CGT was enacted to promote and incentivize the development, expedite the review (and thus approval) of certain previously approved drugs with little or no competition.  In addition,

SaMD (Software as a Medical Device), Medical Device Design Control and the Need for US Guidance

I am currently attending the SDMD (Software Design for Medical Devices) Global IQPC conference in Berlin, where I presented on “Harmonization of Agile Methodology and Medical Device Design Control”.  This topic was chosen because, currently, there is no FDA Guidance on this issue, and to provide insight to developers to implement these systems using a lean,

New OGD Director Named!

Today, the FDA announced the appointment of Sally Choe, PhD to succeed Kathleen (Cook) Uhl, M.D. as Director of the Office of Generic Drugs (Cook’s last day at OGD will be March 2).  Dr. Choe currently serves as Deputy Office Director, Office of Study Integrity and Surveillance within Office of Medical Products and Tobacco, Center for Drug Evaluation and Research,

OGD Has Another Banner Month on the Approvals Front – But Still No Word on Receipts!

OGD just released its official January approval figures and we nailed it in our previous post here, where it was reported that OGD would have 102 approval actions in January, despite the shutdown.  Well, we actually hit the nail on the head, as OGD did indeed break the 100-approval action mark by fully approving eighty-one ANDAs and tentatively approving twenty-one ANDAs.

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Lachman Consultants Services, Inc. Announces Business Exposition Sponsorship of Access! 2019

While concluding its 40th Anniversary Celebration Year with the start of 2019, Lachman Consultants recently announced participation as Business Exposition Sponsor of ACCESS! 2019, the annual meeting of the Association for Accessible Medicines (AAM).

(Westbury, NY – January 2019) Lachman Consultant Services, Inc. a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide will be a prominent participant at ACCESS!

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,