Guidance

06
Jun

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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20
May

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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11
May
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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16
Dec

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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27
Apr

FDA Launches Webpage on COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

FDA recently launched a comprehensive listing of COVID-19 related guidance documents, which can be found here.  Tracking all COVID 19 related documents can be daunting, as the content is being issued at a fast and furious rate, and this website will make that task a little less onerous. The list is filterable, sortable, and can […]

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14
Feb
Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

CBER Publishes a Boatload of New Gene Therapy Guidances

  January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents!  A total of six final guidelines and one draft guideline on GT products were issued.  These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]

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