Food and Drug Administration (FDA)

FDA Comment Deadline: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction

The Food and Drug Administration (FDA) seeks public comments to accompany its September 17, 2019 public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The hearing relates to the draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs.

This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

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

FDA Comment Deadline: Evaluating the Clinical Pharmacology of Oligonucleotide Therapeutics

The Food and Drug Administation (FDA) is establishing a public docket to collect comments on evaluating the clinical pharmacology of oligonucleotide therapeutics. There are many unique clinical pharmacology considerations concerning the development of oligonucleotide therapeutics; however, for the purposes of this request, the Agency is specifically interested in comments regarding the characterization of the effects of hepatic and renal impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of oligonucleotide therapeutics as well as the effects of oligonucleotide therapeutics on cardiac electrophysiology. Public comments will help the Agency develop recommendations for the design and conduct of studies important to the safe and effective use of oligonucleotide therapeutics and facilitate the regulatory assessment of such studies.

Oligonucleotide therapeutics typically are synthetically modified single- or double-stranded ribonucleic acid (RNA) or deoxyribonucleic acid (DNA) that exert pharmacologic effects through a variety of mechanisms (e.g., altered splicing, RNA interference, immunomodulation, microRNA modulation). Compared to small molecule or biological products, oligonucleotide therapeutics have unique characteristics regarding their chemistry, pharmacology, sites of action, pharmacokinetic disposition, and pharmacodynamics. As a result, there may be special considerations for the design and conduct of clinical pharmacology studies to assess oligonucleotide therapeutics, such as those designed to evaluate the effects of organ impairment or drug interactions. Currently, none of FDA's currently published guidance documents on clinical pharmacology assessments contain specific recommendations for oligonucleotide therapeutics.

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

FDA Meeting: Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction

The Food and Drug Administration (FDA) will hold a public hearing entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.” The hearing relates to the draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs.

This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

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

FDA Meeting: Patient Engagement Advisory Committee

The Food and Drug Administration (FDA) will hold a meeting of its Patient Engagement Advisory Committee. The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. 

The Committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. These same features may also increase cybersecurity risks. Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks. The recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication. The recommendations will also address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.

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

FDA Comment Deadline: Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients

The Food and Drug Administration seeks public comments to accompany its August 8, 2019, public workshop titled "Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients." The purpose of the public workshop is to discuss the scientific and clinical trial design considerations for development of antiviral products to treat adenoviral infection.

Discussions are planned around the following topics:

  • Trial design considerations (e.g., trial endpoints, trial populations, treatment strategies, risk/benefit considerations, ethical considerations, virologic testing considerations)
  • Diagnostic assay(s) considerations

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

FDA Nomination Deadline: Vaccines and Related Biological Products Advisory Committee

The Food and Drug Administration (FDA) is seeking nominations from the public and from industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee within the Center for Biologics Evaluation and Research.

The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which FDA has regulatory responsibility. The committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the FDA Commissioner.

Members of the public may submit nominations online at this FDA website, by email, or by mail. More information is available at this Federal Register notice.

FDA Comment Deadline: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products: Content and Format

The Food and Drug Administration (FDA) is announcing the availability of and seeking public comment on a draft guidance for industry entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.” This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of the labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products. The recommendations in this draft guidance will help ensure that the labeling is clear, concise, useful and informative, and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.

This draft guidance is one in a series of guidances FDA is developing or has developed to assist applicants with the content and format of labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule on labeling for human prescription drug and biological products. The final rule and additional guidances on labeling can be accessed online. The labeling requirements and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use.

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