Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

Description

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.” This guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter accelerated approval). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. This guidance finalizes the draft guidance of the same name issued March 25, 2014.

Scope & Applicability

Regulatory Context

• 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .

  The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →

• 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.

  (a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →

• 21CFR601.43§ 601.43 Withdrawal procedures.

  (a) For biological products approved under § 601.41 or § 601.42 , FDA may withdraw approval, following a hearing as provided in part 15 of this chapter , as modified by this section, if:Read full regulation →

• 21CFR314.530§ 314.530 Withdrawal procedures.

  (a) For new drugs approved under §§ 314.510 and 314.520 , FDA may withdraw approval, following a hearing as provided in part 15 of this chapter , as modified by this section, if:Read full regulation →

• 21CFR314.126§ 314.126 Adequate and well-controlled studies.

  (a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →

• 21CFR601.46§ 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 wiRead full regulation →

• 21CFR314.560§ 314.560 Termination of requirements.

  If FDA determines after approval that the requirements established in § 314.520 , § 314.530 , or § 314.550 are no longer necessary for the safe and effective use of a drug product, it will so notify the applicant. Ordinarily, for drug products approved under § 314.510 , these requirements will no loRead full regulation →

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