FDA Guidance Snapshot Pilot Program - Lachman Consultants

CDER to Launch Guidance Snapshot Pilot Program

Those of us in the industry are usually reasonably technically savvy and can understand some of the more complex guidance documents that the FDA issues.  However, there are times that even those among us in the industry, depending on our individual academic tracks and professional experiences, whether regulatory, CMC, bioanalytical, pharmacokinetics, medical, and on and […]

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ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products

CDER has issued the final guidance, ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products, which provides for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM), applying to both drug substances and drug products for chemical entities, therapeutic proteins for new products, and conversion of existing products.  A copy of the guidance […]

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GDUFA III User Fees, Guidances, and MAPPs Published October 5, 2022

There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA.  Rather than trying to paraphrase each Guidance and explain what changes have been made in the past […]

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FDA Withdraws Covid Q&A Document as the FDA Returns to a Semblance of Normalcy

In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication […]

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More PSGs Issued by OGD

Yesterday, the Office of Generic Drugs released twenty-four new and thirteen revised Product Specific Guidances (PSGs) with recommendations for conducting studies necessary to establish bioequivalence between test and reference products.  Of course, the revisions might spell trouble for applicants that have already commenced testing according to the original guidances, but this has been a bone […]

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Businessman reading long paper list

FDA Posts Eight New Guidances This Morning

Covering a multitude of subjects, the Agency published eight new guidance documents ranging from the ICH M9 BCS classification system to a Q&A document on qualified infectious disease designations. Here is a list of the eight guidance documents. M9 Biopharmaceutics Classification System-Based Biowaivers (here) E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis […]

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OGD Finalizes Controlled Correspondence Guidance

While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I.  Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]

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