Lachman Consultant Services, Inc. / Articles by: Bob Pollock
08
Jun

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

By    Jun 08, 2020    Compliance Drug samples FDA PMDA Regulatory Affairs

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?

By    Jun 08, 2020    ANDAs BLA cGMPs Compliance Data Integrity DMFs FDA NDA Regulatory Affairs

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

By    Jun 03, 2020    ANDAs Bioequivalence FDA Generics Regulatory Affairs

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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02
Jun

Additional Guidance on Hand Sanitizer – Preparation, Manufacture and Temporary Compounding: The Bar is Raised

By    Jun 02, 2020    COVID-19 FDA Hand sanitizers Regulatory Affairs

FDA issued three updated guidance documents that have revised recommendations and additional information on the preparation, manufacture, and temporary compounding of hand sanitizers under the COVID-19 public health emergency.  The Agency provides additional guidance on the use of both active and inactive ingredients, updates permitted formulation and denaturing processes, and discusses permissible levels of impurities […]

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01
Jun

Consolidation of Publication for EUAs for Medical Devices Announced in the Federal Register

By    Jun 01, 2020    COVID-19 FDA Medical Devices Regulatory Affairs

The Federal Register (FR), in a pre-publication notice today (here), outlined the general process for the authorization and issuance of emergency use authorizations (EUAs) similar to the ones they have been issuing during the COVID-19 pandemic.  The FDA is (as are other Agencies of the government) authorized to issue EUAs and are required to publish […]

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28
May

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

By    May 28, 2020    ANDAs BLA FDA NDA Regulatory Affairs User Fee Goal Dates User Fees

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

By    May 26, 2020    Biologics FDA Generics ICH Impurities New Drugs Regulatory Affairs

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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21
May

List of Firms That Have Removed COVID-19 Diagnostic Tests

By    May 21, 2020    COVID-19 FDA Medical Devices Regulatory Affairs

Most of the diagnostic tests that are currently being marketed for detecting COVID-19 are subject to emergency use authorizations (EUAs).  Today, the FDA published a listing of commercial manufacturers of serological tests who had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have […]

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