For Patients

Opportunities to Comment Closing - June 2018

The following topics were published in the Federal Register by the Food and Drug Administration (FDA). The intent of this page is to provide patients, caregivers and the general public an opportunity to provide their voice and expertise as a patient to the FDA during the review period.  We have only provided you with a few paragraphs on each topic, if you want to learn more and submit comments, please click on "make comments electronically. 

On this page, you will find the following topics:


Request for comment by June 01, 2018: Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan

FDA announced availability of a draft 5-year plan describing the Agency's approach to further the implementation of structured benefit-risk assessment, including the incorporation of the patient's voice in drug development and decision-making, in the human drug review program and the opportunity for public comment on the draft plan. This new draft plan is an update to the 5-year plan published in February 2013 on FDA's website. This new draft plan is part of FDA's commitments that were made as part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). FDA has published the draft plan on its website. To read the entire Federal Register Notice and to make comments electronically visit www.regulations.gov.


Request for comment by June 08, 2018: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials

FDA announced the availability of a draft guidance for industry entitled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” Currently, collection of safety data on prescription drugs and biological products used during pregnancy usually occurs after approval, and clinicians and patients must undertake a risk-benefit analysis for the use of such products in pregnant women with limited human safety information. Historically, pregnant women have been an understudied population and there have been barriers to obtaining data from pregnant women in clinical trials, including concerns about protecting women and their fetuses from research-related risks. However, data are needed to inform safe and effective treatment during pregnancy, and in certain situations, it is ethically and scientifically appropriate to collect data in pregnant women in clinical trials conducted during drug development.

This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations. To read the entire Federal Register Notice and to make comments electronically, visit www.regulations.gov

 

Request for comment
by June 14, 2018: Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

FDA issued this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health. FDA is using the term “nonaddictive” in this document specifically in the context of a potentially nonaddictive cigarette. We acknowledge the highly addictive potential of nicotine itself depending upon the route of delivery. As discussed elsewhere in this document, questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or nonaddictive for specific members or segments of the population. We envision the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers. The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM. To read the entire Federal Register Notice, visit regulations.gov and to make comments electronically.


Request for comment
by June 18, 2018: Patient-Focused Drug Development on Opioid Use Disorder

The FDA will be holding a public meeting entitled “Patient-Focused Drug Development on Opioid Use Disorder.” The purpose of the public meeting is to obtain patients' perspectives on the impacts of and treatment approaches for opioid use disorder (OUD). This meeting will provide FDA the opportunity to better understand the patient perspective on the impacts of OUD and on treatment approaches for OUD. OUD is the diagnostic term used for a chronic neurobiological disease characterized by a problematic pattern of opioid use leading to significant impairment or distress. OUD includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose, or, if another medical condition is present that required opioid treatment, the opioid is used in doses far greater than the amount needed for treatment of that medical condition. FDA is interested in learning patients' perspectives on OUD, including the effects on their health and well-being that have the greatest negative effect on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for OUD. You can read the entire Federal Register Notice at regulations.gov and also make comments electronically.


Request for comment
by June 19, 2018: Draft Guidance - Post-marketing Safety Reporting for Combination Products

The FDA announced the availability of a draft guidance for industry and FDA staff entitled “Postmarketing Safety Reporting for Combination Products.” This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. This draft guidance is not final nor is it in effect at this time. You can read the entire Federal Register Notice at regulations.gov and also make comments electronically


 

Request for comment by June 19, 2018: Proposed Rulemaking -  Regulation of Flavors in Tobacco Products

FDA issued this advance notice of proposed rulemaking (ANPRM) to obtain information related to the role that flavors play in tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information about, among other things, how flavors attract youth to initiate tobacco product use and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products. FDA is seeking this information to inform regulatory actions FDA might take with respect to tobacco products with flavors, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Potential regulatory actions include, but are not limited to, tobacco product standards and restrictions on sale and distribution of tobacco products with flavors. this advance notice of proposed rulemaking (ANPRM) to obtain information related to the role that flavors play in tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information about, among other things, how flavors attract youth to initiate tobacco product use and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products. FDA is seeking this information to inform regulatory actions FDA might take with respect to tobacco products with flavors, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Potential regulatory actions include, but are not limited to, tobacco product standards and restrictions on sale and distribution of tobacco products with flavors. You can read the entire Federal Register Notice at regulations.gov and also make comments electronically

 

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