Food and Drug Administration (FDA)

FDA Comment Deadline: Patient-Focused Drug Development for Vitiligo

The Food and Drug Administration (FDA) is seeking public comments to accompany the public meeting entitled “Patient-Focused Drug Development for Vitiligo.” The purpose of the public meeting is to allow FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors considered when selecting a treatment. Vitiligo is an autoimmune disease that causes the loss of skin color. The loss of color can affect skin, hair, and other areas of the body. 

The questions that will be asked of patients and patient representatives at the meeting are listed in the following section and organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This discussion will be followed by a facilitated discussion inviting comments from other patients and patient representatives.

This discussion will be followed by a facilitated discussion inviting comments from other patients and patient representatives. In addition to input generated through this public meeting, FDA is interested in receiving patient and patient representative input addressing these questions through written comments, which can be submitted to the public docket. When submitting comments, if you are commenting on behalf of a patient, please indicate that you are doing so and answer the following questions as much as possible from the patient's perspective.

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

FDA Comment Deadline: Patient-Focused Drug Development for Stimulant Use Disorder

The Food and Drug Administration (FDA) is hosting a public meeting titled "Patient-Focused Drug Development for Stimulant Use Disorder" and seeking comments to inform that meeting. This meeting will provide FDA the opportunity to obtain input from individuals who are struggling or have struggled with the use of cocaine, crystal meth, or misuse of prescription stimulants such as Adderall or Ritalin. Family members, advocates, caregivers and other stakeholders are encouraged to participate and share their views on the condition. In particular, FDA is interested in hearing perspectives on the:

  • Health effects and daily impacts of their condition
  • Impact (if any) of opioid and polysubstance use on their condition
  • Treatment goals
  • Decision factors considered when seeking out or selecting a treatment

Members of the public may submit comments online at Regulations.gov, or by mail. For more information, please see this FDA meeting announcement or this Federal Register notice.

FDA Comment Deadline: Modernizing the Food and Drug Administration's Data Strategy

The Food and Drug Administration (FDA) is seeking public comments to accompany the following public meeting entitled “Modernizing FDA's Data Strategy.” The purpose of the public meeting and the request for comments is to discuss possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.

FDA is gathering scientific and technical information to help inform its development of an Agency-wide, strategic approach to modernizing its data strategy, including data quality, data stewardship, data exchange, and data analytics. The Agency has determined that a public meeting and an open public docket will encourage public input and engagement in this important topic.

In September 2019, FDA announced its Technology Modernization Action Plan (TMAP). The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data, and analytics—to advance FDA's public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is responsive to novel technologies and rapidly increasing workloads.

To achieve these goals, FDA intends to develop a modernized Agency-wide, strategic approach not only to technology, but to data itself. Data is at the heart of FDA's work as a science-based Agency, and we anticipate ongoing, rapid increases in the amount and complexity of the data that informs FDA's regulatory decision-making process and how we advance our public health mission.

The Agency welcomes any relevant scientific and technical information related to FDA's consideration of the following topics:

  1. Standards and policy, including:
    1. How can FDA best use policy and common data standards to help ensure the effective and efficient use of data assets?
    2. What are the consequences/issues as we move from “static point-in-time data sets” to updating digital data streams for analyses?
    3. As we move into increased sharing and integrated data sets, how might FDA manage data in a way that avoids unnecessary duplication?
  2. Data security, privacy, and management including:
    1. How can FDA modernize its data strategy to continue ensuring privacy and security of data?
    2. What should FDA do to promote the management and organization of data assets across the Agency, as the amount and complexity of data (e.g., in regulatory submissions to FDA) is rapidly increasing?
  3. Data strategies and data sharing, including:
    1. How can FDA's data strategy facilitate broader goals of integration and interoperability of health care data, and scientific data/virtual patient data generated using scientific models?
    2. How can FDA design its data strategy to reflect a global marketplace and promote clarity to data providers like regulated industry and other stakeholders?
    3. How can FDA design its data strategy and policy development to facilitate appropriate data access, data sharing within the Agency and via data sharing agreements, as well as the appropriate reuse and repurposing of data to advance Agency regulatory science priorities?
    4. For stakeholders, including regulated industry, that submit data to FDA, how can FDA enhance the efficiency of the preparation and submission of data to FDA?

Members of the public may submit comments online at Regulations.gov, or via mail. For more information on the meeting, please see this Federal Register notice or this FDA website.

FDA Comment Deadline: Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed creation of a new collection of information entitled “Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed.”

This generic clearance will allow FDA to use qualitative social/behavioral science data collection techniques (i.e., individual in-depth interviews (IDIs), small group discussions, focus groups, and observations) to better understand stakeholders' perceptions, attitudes, motivations, and behaviors regarding various issues associated with food and cosmetic products, dietary supplements, and animal food and feed. Understanding consumers', manufacturers', and producers' perceptions, attitudes, motivations, and behaviors plays an important role in improving FDA's communications impacting these various stakeholders and in assisting in the development of quantitative study proposals, complementing other important research efforts in the Agency.

Comments may be submitted online at Regulations.gov, or by mail. For more information on the proposed collection activity and comment submission process, please see this Federal Register notice

FDA Comment Deadline: Premarket Tobacco Product Applications and Recordkeeping Requirements

The Food and Drug and Administration (FDA) seeks comments on a proposed rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their tobacco products are legally marketed. The proposed rule would help to ensure that PMTAs contain sufficient information for FDA to determine whether a marketing order should be issued for a new tobacco product, including detailed information regarding the physical aspects of a tobacco product, as well as full reports of information to demonstrate the scope of, and details regarding, investigations that may show the potential health risks of the product.

On March 10, 2020 (85 FR 13840), FDA reopened the public comment deadline regarding aspects related to agency information collection activities to extend to April 9, 2020; the original deadline was November 25, 2019. FDA is taking this action to seek comment on an additional proposed form to collect information that would be required under certain provisions of the proposed rule. This proposed form would allow for easier identification of each new tobacco product contained in a grouped submission of PMTAs.

The proposed rule would codify the general procedures FDA would follow when evaluating PMTAs, including application acceptance, application filing, and inspections, and would also create postmarket reporting requirements for applicants that receive marketing orders. The proposed rule would allow for the submission of PMTAs in alternative formats in certain instances to reduce the burden of submitting a PMTA for modifications to a product that previously received a PMTA marketing order or resubmitting a PMTA to address deficiencies specified in a no marketing order. The proposed rule would also require tobacco product manufacturers to keep records regarding the legal marketing of certain tobacco products without a PMTA, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.

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

FDA Webinar: Analysis of Per and Polyfluoroalkyl Substances (PFAS) in Foods: Analytical Method Development, Challenges, and Successes

The Food and Drug Administration (FDA) will hold a webinar presentation titled "Analysis of Per and Polyfluoroalkyl Substances (PFAS) in Foods: Analytical Method Development, Challenges, and Successes" as part of its Grand Rounds series.

Presenters include:

  • Lowri de Jager, PhD: Branch Chief, Methods Development Branch, Office of Regulatory Science, Center for Food Safety and Applied Nutrition

Members of the public may attend the webinar with advance registration. More information is available at this FDA website.

FDA Comment Deadline: Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed

The Food and Drug Administration (FDA) is announcing the availability of and seeking public comments on a draft guidance for industry entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”

When finalized, this draft guidance will provide recommendations to applicants seeking licensure under the Public Health Service Act (the PHS Act) of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product's licensed conditions of use. Additionally, when finalized, this draft guidance will also provide recommendations on the submission of a supplement to a licensed biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.

Members of the public may submit comments on this draft guidance online at Regulations.gov, or by mail. For more information on this draft guidance, please see this Federal Register notice.

FDA Comment Deadline: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products

The Food and Drug Administration (FDA) is announcing the availability of and seeking public comments on a draft guidance for industry entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products—Questions and Answers.” FDA is issuing this guidance to provide manufacturers, packers, distributors, and their representatives (firms) with information to consider when developing FDA-regulated promotional labeling and advertisements (promotional materials) for prescription reference and biosimilar products licensed under the Public Health Service Act (PHS Act). Although the guidance covers promotional issues involving both reference and biosimilar products, some questions and answers are focused on only biosimilar product promotional materials. The guidance does not discuss considerations unique to promotional materials for interchangeable biosimilars.

Comments on this draft guidance may be submitted electronically at Regulations.gov, or by mail. For more information on this draft guidance, please see this Federal Register notice.

The US Food and Drug Administration is green lighting new drugs faster than ever

Quartz–The US Food and Drug Administration, the regulatory body that authorizes drugs to be sold on the market, approved more drugs annually on average in the last decade than it did in the decades starting in 1990 and 2000, researchers from Brigham and Women’s Hospital and Harvard University reported in an article published this week (paywall).

New Joint Website on Agricultural Biotechnology Products Launched by EPA, USDA, and FDA

The National Law Review — On January 9, 2020, the EPA, Office of Pesticide Programs (OPP) in coordination with the USDA and the FDA announced the launch of a new website that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.