24
Jun

Any Interest in Homeopathic Drugs? 34,341 Comments Suggests So!

The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog.  The most recent post on this topic was on June 17, 2020 (here).  That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters.  […]

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11
Jun

Process MaPP for Conversion of Approved ANDA to TA after Finding of Patent Infringement

Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA).  The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]

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08
Jun

Temporary Provisions for Prescription Drug Sample Delivery and Receipt during the COVID-19 Pandemic Public Health Emergency

The FDA issued an immediately effective guidance today titled Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency (here).  This guidance (which will stay in effect until the public health emergency [PHE] is over) will provide additional flexibility for healthcare providers and distributors of record […]

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08
Jun

Data Integrity Issues Still Plague Pharmaceutical Manufacturers – Where’s the Beef?

I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]

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03
Jun
New and Revised Bio Guidances Issued by OGD Image

New and Revised Product Specific Bioequivalence Recommendations List Update

The FDA announced today the addition of 25 new bioequivalence (BE) recommendations and has issued revisions of 24 previous recommendations.  FDA continues its efforts in getting ahead of the curve trying to issue BE recommendations for “(1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to […]

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28
May

Meeting and Application Goal Dates – Questions and Answers of Impact of COVID-19 Work

The FDA released a guidance to remain in effect until the COVID-19 public health emergency is resolved titled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers ( here).  In this guidance, the Agency addresses many questions they have been asked about scheduling meetings, face-to-face (FTF) […]

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26
May

New Recommended PDE Limits for Three Solvents Proposed by ICH

Today, in the Federal Register pre-publication notice (here), “the Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME), and tert-butyl alcohol (TBA).”  The recommendations are based on the testing parameters established for developing permitted […]

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14
May

Lachman OnCall™ GMP Teleconsulting for the Life Sciences

Need answers to your urgent life science questions? Lachman Consultant Services, Inc. (Lachman Consultants) has launched Lachman OnCallTM GMP Teleconsulting. It’s your opportunity to speak to our Subject Matter Experts (SMEs) regarding your questions as they occur. Whether you have questions about compliance or a complex scientific or technical issue, we’re here and ready to […]

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