FDA releases final guidance on Clinical Pharmacology section of drug labeling

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FDA releases final guidance on Clinical Pharmacology section of drug labeling

Is it the clinical pharmacology section of generic drugs and biologic’s labels requiring your attention? Are you chalking out a plan to gather the related data? Then it is the time you should know about Food and Drug Administration’s (FDA’s) finalized guidance on labeling. Here’s a quick overview.

What is Clinical Pharmacology?

Clinical pharmacology denotes how a drug is expected to affect a patient using the drug, and it includes information obtained from pharmacodynamics (PD), pharmacokinetic (PK) research (i.e. a drug’s interaction with the body, and to what extent), and from adverse event and toxicology data obtained from clinical studies. Apart from critical aspect for approval purposes, the Clinical Pharmacology data stands an integral part of a drug labeling. Clinical Pharmacology data can be availed to inform:

  • to inform prescribing decisions
  • to prevent dangerous drug-drug reactions
  • to warn consumers about risks associated with the drugs

With an intention to ensure and maintain consistency of both format and content for all the prescription drugs to be approved, the FDA’s finalized guidance on drug labeling with respect to Clinical Pharmacology section offers recommendations applicants of NDAs and supplements, ANDAs, and BLAs and supplements who intend to prepare or amend the clinical pharmacology information in the labeling for human prescription drugs. The first draft of this FDA guidance was released way back in 2009 to reach the goals first established in its 2006 Physician Labeling Rule (PLR). To further clarify the information stated in the guidance, FDA released a revised version of the draft guidance in 2014. Discussing further on the data requirements, FDA in a recently released guidance clarified certain aspects on

  • Mechanism of Action
  • Pharmacodynamics
  • Pharmacokinetics

Besides such detailed clarifications, FDA also includes a new section at the end of the guidance that stresses that companies do not need to submit a labeling supplement just to address a minor formatting change that is not a regulatory or safety issue. Instead, any minor formatting changes, FDA says, should in turn be documented and included in the product’s next annual report. We understand how cumbersome it can get to be updated with the best practices and compliant Regulatory labeling know-how. It’s perhaps time to consult a global labeling partner to stay afloat.