Regulatory Developments January 2019


Proposed rule, FDA workshop and meetings, FDA guidance, and NIH announcements on inventions available for licensing.

Proposed Rule

FDA would provide an exception from the requirement to obtain informed consent for a clinical investigation that poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The rule would allow an Institutional Review Board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain minimal risk clinical investigations regulated by the agency. The rule would require the IRB to find and document four criteria to comply with the Common Rule. Comments are due Jan. 14, 2019. Contact: Janet Norden; FDA, Office of Good Clinical Practice; +1.301.796.1127; Citations: 21 CFR 50.20, 50.22, 312.60, 812.2. 83 Fed. Reg. 57,378; 11/15/2018.



FDA intends to seek OMB approval for a revised information collection request regarding a guidance on tropical disease priority review vouchers. The guidance addresses requirements for priority review voucher requests, the intent to use a priority review voucher, and transferring priority review vouchers to other sponsors of certain tropical disease drug product applications. The revision addresses requirements for sponsors of tropical disease product applications to include attestations regarding their eligibility for a priority review voucher. Comments are due Jan. 7, 2019. Contact: Domini Bean; FDA, Office of Operations; +1.301.796.5733; 83 Fed. Reg. 55,720; 11/7/2018.


FDA announces a workshop to discuss a draft guidance for industry regarding the assessment of the pressor effects of drugs. The agenda includes discussions about the risks associated with blood pressure changes, FDA analyses related to ambulatory blood pressure monitoring, evaluating a drug’s effect on blood pressure, and understanding the optimal regulatory approach to assigning risk. The workshop is scheduled for Feb. 4, 2019, in Washington, D.C., and via webcast. Contact: Norman Stockbridge; FDA, Center for Drug Evaluation and Research (CDER); +1.301.796.2240; 83 Fed. Reg. 57,490; 11/15/2018.


FDA announces meetings on electronic submission of adverse event reports to the FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) standards. The agenda for all three meetings includes a presentation regarding FDA’s plan to incorporate the standards for drug, biological, and drug/biologic-led combination product submissions for the premarket and postmarket safety surveillance programs managed by CDER and CBER by April 2020. The agenda also includes discussions regarding enhancements to electronic submissions of individual case safety reports (ICSRs) in FAERS using the standards and public comments by industry representatives. In addition, the agenda includes discussions regarding E2B(R3) regional data elements and usage of data standards, submission paths for premarket and postmarket ICSRs, data migration exceptions, and regional implementation specifications. The meetings are scheduled for Jan. 25 and July 17, 2019, and Feb. 19, 2020, all in Silver Spring, Md., and via webcast. Comments for each individual meeting are due Feb. 25, 2019; Aug. 6, 2019; and March 20, 2020, respectively. Contact: Suranjan De; FDA, CDER; +1.240.402.0498; 83 Fed. Reg. 57,732; 11/16/2018.


NIH announces an invention available for licensing for commercial development owned by the U.S. government. The technology involves a set of influenza virus enrichment probes developed to increase the sensitivity of sequence-based universal detection of all influenza viruses. The commercial applications include influenza diagnostics and surveillance. Contact: Jenish Patel; NIH, National Institute of Allergy and Infectious Diseases; +1.240.669.2894; 83 Fed. Reg. 55,904; 11/8/2018.


The National Institute of Allergy and Infectious Diseases (NIAID) announces a government-owned invention available for licensing for commercial development. The technology involves methods for diagnosing and treating Mycobacterium tuberculosis infection through detection of CD153 expression level. The commercial applications include a diagnostic to measure the production of CD153 as a disease indicator, a companion diagnostic to determine the effectiveness of a vaccine, and therapeutic applications. Contact: James Robinson; NIH, NIAID; +1.301.761.7542; 83 Fed. Reg. 55,906; 11/8/2018.

FDA Guidance

FDA announces the availability of a draft guidance, Meta-Analyses of Randomized Controlled Clinical Trials [RCTs], to evaluate the safety of human drugs or biological products. It outlines principles of design, conduct, and reporting that the agency intends to apply to meta-analyses it conducts and to use as benchmarks when evaluating meta-analyses conducted by sponsors or third parties. It is intended to assist applicants submitting investigational new drug applications, new drug applications, biologics license applications, or supplemental applications as well as third-party entities that prepare or evaluate meta-analyses assessing the safety of drug products. Comments are due Jan. 7, 2018.* 83 Fed. Reg. 55,722; 11/7/2018.

FDA announces the availability of a draft guidance for industry, Metastasis-Free Survival Endpoint in Clinical Trials for Prostate Cancer Drugs, for clinical trials for nonmetastatic, castration-resistant prostate cancer drug or biological product development programs. Comments are due Jan. 14, 2019.* 83 Fed. Reg. 56,857; 11/14/2018.


FDA announces the availability of a final guidance for industry, Developing Fixed-Dose Combination Drugs for Hypertension Treatment. The guidance focuses on development of two-drug combinations of previously approved drugs. Contact: Naomi Lowy; FDA, CDER; +1.301.796-0692. 83 Fed. Reg. 55,728; 11/7/2018.

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Regulatory Developments
January 2019