Food and Drug Administration (FDA)

FDA Comment Deadline: Limited Population Pathway for Antibacterial and Antifungal Drugs

The Food and Drug Administration (FDA) is seeking public comments on the draft guidance for industry, “Limited Population Pathway for Antibacterial and Antifungal Drugs,” that was published in the Federal Register on June 13, 2018 (83 FR 27616). FDA is reopening the comment period on this draft guidance for comments to be submitted for consideration before they finish work on the final version of the guidance.

This draft guidance is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the limited population pathway for antibacterial and antifungal drugs. This draft guidance also is intended to assist sponsors in developing labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section of the Federal Food, Drug, and Cosmetic Act. 

Members of the public may submit comments via mail, fax, or at Regulations.gov. More information is available at this Federal Register notice and on this FDA website

FDA Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs

The Food and Drug Administration (FDA) is announcing the following public meeting entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The purpose of the meeting is to provide a public forum for FDA to listen to comments on the draft guidance for industry, “Limited Population Pathway for Antibacterial and Antifungal Drugs,” that was published in the Federal Register on June 13, 2018 (83 FR 27616).

This draft guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). This draft guidance is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway. This draft guidance also is intended to assist sponsors in developing labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section 506(h) of the FD&C Act. The LPAD pathway is intended to encourage the development of certain antibacterial and antifungal drugs for limited and specific populations of patients to help address the critical public health and patient care concern that has resulted from the current decline in antibacterial and antifungal drug research and development as serious antibacterial and antifungal drug-resistant infections increase.

FDA is holding a public meeting to receive information and comments concerning the draft guidance on the LPAD pathway from a broad group of stakeholders, including patients, researchers, healthcare providers, manufacturers, interested industry, professional organizations, and the public. The Agency has determined that a public meeting is the most appropriate way to ensure public engagement on the draft guidance. FDA welcomes any relevant information that stakeholders wish to share.

Members of the public may attend in person with advance registration, or via webcast. More information is available at this Federal Register notice and on this FDA website

FDA Comment Deadline: Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds

The Food and Drug Administration (FDA) is seeking public comments to accompany an upcoming public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products. These questions could impact the approaches we consider taking in regulating the development and marketing of products.

Given the substantial interest in this topic and Congressional interest in fostering the development of appropriate hemp products under the 2018 Farm Bill, while also preserving FDA's ability to protect the public health, FDA is holding a public hearing. The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds, both from botanical and synthetic sources, to inform our regulatory oversight of these products. FDA does not intend for this hearing to produce any decisions or new positions on specific regulatory questions, but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.

Members of the public may submit comments via mail, fax, or at Regulations.gov. More information is available at this Federal Register notice

FDA Comment Deadline: Amendments to Regulations on Records, Reports, and Performance Standards for Radiation Emitting Electronic Products

The Food and Drug Administration (FDA) is seeking comments on a proposed rule to amend and repeal parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The FDA is proposing this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices. The FDA is comprehensively reviewing existing regulations to identify opportunities for repealing and amending regulations that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

This proposed rule would amend and repeal certain regulations for radiation emitting electronic products and medical devices because FDA has identified the regulations as being outdated and duplicative of other means for reducing radiation exposure to the public. The FDA is proposing to update the regulations to reduce regulations that are outdated and otherwise clarify requirements for protecting the public health against radiation exposure from specific electronic products and medical devices. The regulations being proposed for amending or repealing are the radiation protection recommendations for specific uses, records and reporting requirements for electronic products, applications for variances, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products.

Members of the public may submit comments via mail, fax, or at Regulations.gov. More information is available at this Federal Register notice

FDA Comment Deadline: Clinical Utility and Safety Concerns Associated with Higher Ranges of Opioid Analgesic Dosing in the Outpatient Setting

The Food and Drug Administration (FDA) is seeking public comments to accompany a forthcoming meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. At the meeting, FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. FDA is also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients.

FDA frequently hears from patients and healthcare providers that higher-dose opioid analgesics continue to be a unique and necessary part of effective pain management for some patients. FDA is also cognizant of serious safety concerns associated with both higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may access these drugs. Higher strength products may be more harmful in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse. Along with a number of other factors, a higher daily opioid dose is associated with greater risk of overdose. Concerns have also been raised that higher dose opioid regimens may carry a higher risk of addiction, although robust evidence for a causal relationship is lacking. There is a strong association between higher opioid dose and duration/persistence of opioid analgesic therapy and assessing temporal relationships and independent effects of opioid dose and duration on the risks of both addiction and overdose is challenging. In addition, FDA acknowledges the complex and evolving landscape of the opioid epidemic, with myriad Federal, State, local, and payer efforts to encourage more judicious prescribing of opioid analgesics, and the growing threat of highly lethal illicit opioids.

To better understand both the clinical utility and harms of higher dose opioid analgesics in the current environment, and to discuss the advantages and disadvantages of various potential risk-management strategies, FDA brings these issues to an advisory committee to seek input and advice from the clinical, patient, public health, and research communities.

In particular, FDA seeks to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose.

Members of the public may submit comments online at Regulations.gov. More information is available at this Federal Register notice.

FDA Meeting: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

The Food and Drug Administration (FDA) will hold a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. 

During the morning session, the particular matter for this meeting will be review and discussion of the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website. FDA is required by statute to review and update the previously approved and published lists. The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment. Planned introductory presentations will be on: (1) Cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors.

During the afternoon session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ONC201, presentation by Oncoceutics Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

Members of the public may attend in person. More information is available at this Federal Register notice.

FDA Comment Deadline: Bispecific Antibody Development Programs

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bispecific Antibody Development Programs.” This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development.

This draft guidance discusses general considerations and recommendations, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody development programs. This draft guidance does not discuss development considerations for other multitarget therapies that are combinations of monoclonal antibodies, antibody cocktails, or polyclonal antibodies.

Members of the public may submit comments via mail, fax, or at Regulations.gov. More information is available at this Federal Register notice