Avid Bioservices Inc (CDMO)

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(c) Determine whether the studies involving the investigational drug or
device may continue.7 If the Commissioner determines, after
unreliable data submitted by the disqualified investigator are

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FDA may determine that further use of the investigational product should be suspended at the
investigator’s site (or a more broad suspension, depending on the circumstances). However, if this
suspension could create a life-threatening situation for a subject under the disqualified investigator’s care,
FDA may permit that subject to continue to receive or use an investigational product. Matters where a
subject may be at risk if the study is suspended, among other relevant matters, may be brought to the
agency’s attention during the regulatory hearing.
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Contains Nonbinding Recommendations
eliminated from consideration, that the data remaining are inadequate
to support a conclusion that it is reasonably safe to continue the
investigation, the Commissioner will notify the sponsor who will have
an opportunity for a regulatory hearing under 21 CFR part 16. If a
danger to public health exists, however, the Commissioner will
terminate the IND or IDE immediately and notify the sponsor of the
determination.8 The sponsor will then have an opportunity for a Part
16 regulatory hearing to determine whether the IND or IDE should be
reinstated. (21 CFR 312.70(d) and 21 CFR 812.119(d)).

(d) Determine whether the continued marketing approval of the product is
justified (e.g., any approved product for which the investigator’s data
were pivotal to FDA decision-making). If continued approval is not
justified, the Commissioner will proceed to withdraw approval in
accordance with applicable provisions of the Federal Food, Drug, and
Cosmetic Act. (21 CFR 312.70(e) and 812.119(e)).