Regulatory Perspectives - A Review of FDA Draft Guidance

Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn. This was due to problems associated with the method and also inconsistencies and variability in the resulting data. The purpose of this study was to re-visit the tape stripping technique, incorporate refinements to reduce variability and validate the method using bioequivalence data obtained from the assessment of a topical corticosteroid cream containing 0.05% clobetasol propionate using the human skin-blanching assay. Methods: A pilot tape stripping study was conducted to establish the variability of the formulations.The bioequivalence of two different commercially available clobetasol propionate cream formulations and a clobetasol propionate ointment formulation were subsequently investigated using the tape stripping method. Results: The data from the pilot tape stripping study correlated well with data from the human skin-blanching assay. A subsequent pivotal tape stripping study confirmed bioequivalence between the two cream formulations whereas bio-inequivalence was demonstrated between the cream and ointment formulations.Conclusions: These studies show that the results from tape stripping concur with data from the human skin blanching assay and demonstrate the potential of a well-controlled tape stripping study as an option for the assessment of bioequivalence of topical corticosteroid formulations.

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Outcome of the public consultation on the draft Guidance on the assessment of the safety of feed additives for the consumer

EFSA Supporting Publications ◽

10.2903/sp.efsa.2017.en-1305 ◽

2017 ◽

Vol 14 (10) ◽

Author(s):

Keyword(s):

Feed Additives ◽

Public Consultation ◽

Draft Guidance ◽

The Public

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VP165 Landscape Assessment: Patient Engagement In Health Technology Assessment

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317004019 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 224-225

Author(s):

Elisabeth Oehrlein ◽

Jason Harris ◽

Nicole Labkoff ◽

Eleanor Perfetto ◽

Manal Ziadeh ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Patient Engagement ◽

Public Involvement ◽

Web Search ◽

Health Technology ◽

Public Consultation ◽

Patient Questionnaire ◽

Draft Guidance ◽

Stakeholder Consultation

INTRODUCTION:Understanding the current landscape of patient engagement across value decision-making bodies internationally is a critical first step toward improving the patient centricity of Health Technology Assessment (HTA). This study assessed: (i) Terms and definitions used; (ii) Patient engagement opportunities; (iii) Evidence of patient engagement.METHODS:A sample of country-specific HTA's (HTA; n = 6), professional organizations (PO; n = 4), and collaborations/independent organizations (CO; n = 3) was selected for representativeness. Information was gathered through: (i) targeted web search and (ii) emailing organizations directly. Definitions, HTA methods documents, and the three most recent evaluations were identified, abstracted, and compared. Data were collected between September-October 2016.RESULTS:Numerous terms are used to describe patient engagement: patient input (HTA = 1, PO = 1), patient-group submitted information (HTA = 1), cooperation with patients/users (HTA = 1), public consultation (HTA = 1), patient perspectives (HTA = 1, PO = 1), involvement of people affected (HTA = 1), patient involvement (HTA = 2), patient and public involvement (HTA = 1), lay involvement (HTA = 1), inclusion of patient representative (PO = 3), patient reports (PO = 1), patient preference (PO = 2), public consultation (CO = 1), stakeholder consultation (CO = 1), open input (CO = 1), stakeholder engagement (CO = 1), and patient participation (CO = 1). Opportunities for patient engagement were described as: patient questionnaire (HTA = 2); comment period (HTA = 1; CO = 1); committee participation (HTA = 3; PO = 3); propose topics (HTA = 1); draft guidance (HTA = 1); general stakeholder forum (CO = 1). While organizations outline opportunities for patient engagement, not all organizations have clear evidence the practices are used or have impact. Recent evaluations demonstrate clear evidence of engagement (HTA = 2); Unclear or mixed evidence (HTA = 1; PO = 1; CO = 2); No evidence (HTA = 3; PO = 3; CO = 1).CONCLUSIONS:There is substantial heterogeneity in the terms used to describe patient engagement activities across organizations. While a variety of opportunities for patient engagement are described, lack of clear evidence to how patient engagement practices are consistently used may contribute to the perception that engagement by HTAs.

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