Regulatory Update

Regulatory Update, October 2015

Thursday, October 1, 2015

FDA Issues Several Draft Guidance Documents

Since the last issue, FDA released six draft guidance documents in the Federal Register. Interested persons should submit electronic or written comments on draft FDA guidance documents by the date specified (in parentheses) to have their comments considered for preparation of the final document, but comments will be accepted at any time and may be used in the future. Submit comments as instructed above. Identify comments with the associated Docket number (also in parentheses).

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Regulatory Update, September 2015

Tuesday, September 1, 2015

FDA Draft Guidance on Male-Mediated Developmental Risks for Pharmaceuticals

In the June 12, 2015 Federal Regis­ter, FDA announced the availability of a draft guidance titled Assessment of Male-Mediated Developmental Risk for Phar­maceuticals. This draft guidance provides recommendations to sponsors for assess­ing risks to embryo/fetal development re­sulting from administration of an active pharmaceutical ingredient (API) to males either through an effect on the male germ cell or from fetal exposure following semi­nal transfer of a potentially developmental toxicant to pregnant females. The need for measures to mitigate the risk to embryo/fetal development posed by males partici­pating in clinical trials also is addressed.

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Regulatory Update, August 1025

Saturday, August 1, 2015

FDA seeks help from stakeholders on direct electronic source data to EDC

In the June 26, 2015 Federal Register, the Food and Drug Administration’s (FDA) Cen­ter for Drug Evaluation and Research (CDER) announced it is interested in supporting dem­onstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, using established data and imple­mentation standards in a regulated clinical re­search environment. A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research infor­mation within a single system and workflow. Stakeholders may include regulated industry, EHR/EDC vendors, academic medical centers, and other interested parties.

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Regulatory Update, July 2015

Wednesday, July 1, 2015

FDA draft guidance on individual patient expanded access application form

In the February 10 Federal Register, FDA announced the availability of a draft guid­ance for industry titled Individual Patient Expanded Access Applications: Form FDA 3926. The draft guidance seeks public com­ment and describes draft Form FDA 3926 (Individual Patient Expanded Access—In­vestigational New Drug Application [IND)], which, when made final, FDA intends to make available for licensed physicians to use for expanded access requests for in­dividual patient INDs. Individual patient expanded access allows for the use of an in­vestigational drug outside of a clinical trial for an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. When made final, draft Form 3926 should provide a streamlined alternative for sub­mitting an Investigational New Drug Ap­plication (IND; Form FDA 1571) for use in cases of individual patient expanded access.

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Regulatory Update, June 2015

Monday, June 1, 2015

FDA draft guidance on acceptance of medical device clinical data from studies conducted outside the U.S.

The FDA has announced availability of a draft guidance titled Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff. This draft guidance articulates the FDA’s current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for devices.

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Regulatory Update, May 2015

Friday, May 1, 2015

FDA draft guidance on premarket studies of implantable minimally invasive glaucoma surgical devices

The FDA has announced availability of a draft guidance for industry titled Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices. This leapfrog guidance document was developed to notify manufacturers of the recommended nonclinical and clinical studies to support a premarket approval application (PMA) for implantable MIGS devices. When made final, this draft guidance will recommend non-clinical and clinical studies support a PMA for implantable MIGS devices.

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Regulatory Update, April 2015

Wednesday, April 1, 2015

FDA seeks comments on identifying potential biomarkers important to drug development

The FDA is seeking information to facilitate development and qualification of biomarkers in areas related to human drug therapeutics. The FDA is encouraging interested groups and individuals to submit information on specific medical and biological areas in which novel biomarkers can be identified that would mean­ingfully advance drug development. The FDA encourages respondents to describe evidentia­ry considerations that are important to qualify these biomarkers for a specific context of use.

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Regulatory Update, March 2015

Sunday, March 1, 2015

FDA guidance on developing vaginal Microbicides for Preventing HIV Infection

The FDA has announced the availability of a guidance document titled Vaginal Microbicides: Development for the Prevention of HIV Infection. The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides, defined as vaginal drug products that prevent human immunodeficiency virus (HIV) acquisition.

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Regulatory Update, February 2015

Sunday, February 1, 2015

DHHS proposed rule on clinical trial registration and results submission

The Department of Health and Human Services (DHHS) has announced a proposed rule on clinical trial registration and results submission. It proposes requirements for sponsors or principal investigators submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and medical devices, and for pediatric postmarket surveillances of a medical device, to ( This proposed rule provides for the expanded registry and results data bank specified in the FDA Amendments Act of 2007 (FDAAA) to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information and enhance patient access to and understanding of clinical trial results. The executive summary is presented here.

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Regulatory Update, January 2015

Thursday, January 1, 2015

FDA draft guidance for laboratory developed tests

The FDA has announced availability of a draft guidance titled Framework for Regula­tory Oversight of Laboratory Developed Tests (LDTs). This document describes a risk-based framework for addressing the regulatory over­sight of a subset of in vitro diagnostic (IVD) devices called LDTs, intended for clinical use and designed, manufactured and used within a single laboratory. This document describes the FDA’s priorities for enforcing pre- and post-market requirements for LDTs, and the process by which the FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time.

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