0338 21cfr601 45 2007

Food and Drug Administration, HHS

§ 601.51

(1) An advisory committee duly constituted under part 14 of this chapter
will be present at the hearing. The
committee will be asked to review the
issues involved and to provide advice
and recommendations to the Commissioner of Food and Drugs.
(2) The presiding officer, the advisory
committee members, up to three representatives of the applicant, and up to
three representatives of the Center
may question any person during or at
the conclusion of the person’s presentation. No other person attending the
hearing may question a person making
a presentation. The presiding officer
may, as a matter of discretion, permit
questions to be submitted to the presiding officer for response by a person
making a presentation.
(f) Judicial review. The Commissioner’s decision constitutes final
agency action from which the applicant may petition for judicial review.
Before requesting an order from a
court for a stay of action pending review, an applicant must first submit a
petition for a stay of action under
§ 10.35 of this chapter.

the labeling or initial publication of
the advertisement.
§ 601.46 Termination of requirements.
If FDA determines after approval
that the requirements established in
§ 601.42, § 601.43, or § 601.45 are no longer
necessary for the safe and effective use
of a biological product, it will so notify
the applicant. Ordinarily, for biological
products approved under § 601.41, these
requirements will no longer apply when
FDA determines that the required
postmarketing study verifies and describes the biological product’s clinical
benefit and the biological product
would be appropriate for approval
under traditional procedures. For biological
products
approved
under
§ 601.42, the restrictions would no
longer apply when FDA determines
that safe use of the biological product
can be assured through appropriate labeling. FDA also retains the discretion
to remove specific postapproval requirements upon review of a petition
submitted by the sponsor in accordance
with § 10.30.

Subpart F—Confidentiality of
Information

[57 FR 58959, Dec. 11, 1992, as amended at 68
FR 34797, June 11, 2003; 70 FR 14984, Mar. 24,
2005]

§ 601.50 Confidentiality of data and information in an investigational new
drug notice for a biological product.
(a) The existence of an IND notice for
a biological product will not be disclosed by the Food and Drug Administration unless it has previously been
publicly disclosed or acknowledged.
(b) The availability for public disclosure of all data and information in an
IND file for a biological product shall
be handled in accordance with the provisions established in § 601.51.
(c) Notwithstanding the provisions of
§ 601.51, the Food and Drug Administration shall disclose upon request to an
individual on whom an investigational
biological product has been used a copy
of any adverse reaction report relating
to such use.

§ 601.44 Postmarketing safety reporting.
Biological products approved under
this program are subject to the postmarketing recordkeeping and safety
reporting applicable to all approved biological products.
§ 601.45

Promotional materials.

For biological products being considered for approval under this subpart,
unless otherwise informed by the agency, applicants must submit to the
agency for consideration during the
preapproval review period copies of all
promotional materials, including promotional labeling as well as advertisements, intended for dissemination or
publication within 120 days following
marketing approval. After 120 days following marketing approval, unless otherwise informed by the agency, the applicant must submit promotional materials at least 30 days prior to the intended time of initial dissemination of

[39 FR 44656, Dec. 24, 1974]

§ 601.51 Confidentiality of data and information in applications for biologics licenses.
(a) For purposes of this section the
biological product file includes all data

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