Regulatory Update

Regulatory Update, October 2017

Sunday, October 1, 2017

FDA Final Guidance on Waiver or Alteration of Informed Consent

In the July 25, 2017, Federal Register, the FDA announced the availability of a final guidance for sponsors, investigators, and institutional review boards (IRBs) titled, “IRB Waiver or Alteration of Informed Consent for Clinical Investigations In­volving No More Than Minimal Risk to Human Subjects.” It informs sponsors, in­vestigators, IRBs and other interested par­ties that the FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, the guidance explains that the FDA does not intend to object to a sponsor initiating, or an inves­tigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance.

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Regulatory Update, August 2017

Tuesday, August 1, 2017

FDA Draft Q&A Guidance on Electronic Records and Electronic Signatures

In the June 21, 2017, Federal Register, the FDA announced the availability of a draft guidance for industry titled, ‘‘Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.’’ This document pertains to sponsors, clinical investigators, institutional review boards (IRB), CRO and other interested parties who use electronic records, electronic signatures and electronic systems in FDA-regulated clinical investigations and who send certain required information to the FDA or others who keep certain required records and make them available during FDA inspections.

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Regulatory Update, May 2017

Monday, May 1, 2017

FDA Publishes Final Guidance Documents

Interested parties may submit electronic or written comments on these final guidance documents at any time, as instructed for the first document and with the indicated Docket Number included in the comments.

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Regulatory Update, April 2017

Saturday, April 1, 2017

FDA Draft Guidance on Multiple Endpoints in Clinical Trials

In the January 13, 2017, Federal Register, the FDA announced the availability of a draft guidance titled, “Multiple Endpoints in Clinical Trials.” This draft provides sponsors and review staff with the FDA’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well-recognized statistical methods for managing multiplicity within a study to control the chance of making erroneous conclusions about a drug’s effects.

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Regulatory Update, March 2017

Wednesday, March 1, 2017

FDA Bans Powdered Gloves and Absorbable Powder for Lubricating Gloves

In the December 19, 2016, Federal Register, the FDA announced its determination that powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. The FDA banned these devices in this published final rule, effective January 18, 2017. All powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s gloves must be removed from the market upon the effective date.

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Regulatory Update, February 2017

Wednesday, February 1, 2017

FDA Publishes Draft Guidance Documents

Although the dates for submitting comments to some of these will have passed before publication, interested parties should still consider submitting comments on these drafts as instructed, with the indicated Docket Number included in the comments.

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Regulatory Update, January 2017

Sunday, January 1, 2017

FDA Publishes Several Draft Guidance Documents

The FDA published several draft guidance documents. Although the dates for submit­ting comments will have passed before this is­sue is distributed, interested parties should still consider submitting comments on these draft documents with the indicated Docket Number included in the comments.

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Regulatory Update, December 2016

Thursday, December 1, 2016

FDA Publishes Final Guidance Documents

The FDA published these final guidance documents. Interested parties may submit electronic or written comments on these guidance documents as instructed for the first document and with the indicated Docket Number included in the comments.

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Regulatory Update, November 2016

Tuesday, November 1, 2016

Proposed Changes to NIH Guide­lines for Human Stem Cell Research

In the August 5, 2016 Federal Register, the NIH requested public comment on a proposal to amend Section IV and Section V of the NIH Guidelines for Human Stem Cell Research and on the proposed scope of certain human-animal chimera research that will be considered internally by an NIH steering committee to provide program­matic input to the director of the relevant NIH Institute(s) or Center(s) or equivalent NIH officials responsible for funding deci­sions. The comment period was extremely brief, ending on September 6, 2016.

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Regulatory Update, October 2016

Saturday, October 1, 2016

FDA Publishes Several Draft Guidance Documents

The FDA recently published several draft guidance documents related to the treatment of particular diseases. Interested parties may submit electronic or written comments on these draft guidance documents as instructed above by the dates indicated below and with the indicated Docket Numbers included in the comments.

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