FDA is announcing the availability of a draft guidance for industry entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment or prevention of smallpox (variola virus) infection. This draft guidance addresses nonclinical development, key study design considerations for animal efficacy studies to support potential new drug application (NDA)/biologics license application (BLA) submissions under the animal rule (21 CFR part 314, subpart I, for drugs and 21 CFR part 601, subpart H, for biologics), and considerations for obtaining a human safety database.
This draft guidance revises the draft guidance for industry entitled “Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention” issued on November 23, 2007 (72 FR 65750). The revisions intend to streamline the guidance and incorporate input from a public workshop in 2009 and an advisory committee meeting in 2011. This revision contains the following changes:
This draft guidance revises the draft guidance for industry entitled “Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention” issued on November 23, 2007 (72 FR 65750). The revisions intend to streamline the guidance and incorporate input from a public workshop in 2009 and an advisory committee meeting in 2011. This revision contains the following changes:
- Modification and integration of several sections to focus on multidisciplinary considerations for studies in animal models of orthopoxvirus disease, including:
- Considerations for preliminary assessments of antiviral activity in animal models
- Key study design considerations for animal efficacy studies to support potential NDA/BLA submissions under the animal rule
- Selection of an effective dose in humans
- Additional clarification on the following:
- Key nonclinical virology issues related to drug development under the animal rule
- Key pharmacology/toxicology issues
- Considerations regarding healthy volunteer safety trials, safety data from non-smallpox clinical experience, clinical trials in the event of a public health emergency, individual patient expanded access investigational new drug applications for emergency use, and emergency use authorization
- Key clinical pharmacology issues that may be affected by limitations in collecting clinical data
- Key chemistry, manufacturing, and controls issues, such as the importance of developing formulations for patients who are unable to swallow solid oral dosage formulations, as well as the importance of generating stability data needed to support a long expiration dating period
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