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FDA Reviews Outdated Guidance Documents



FDA announced that the Center for Drug Evaluation and Research (CDER) has reviewed the status of draft guidance documents issued before 2010 to determine what should be done with those guidance documents going forward. According to the Federal Register, CDER will withdraw guidance documents that are not up to date and lack current information. CDER will determine which guidance documents reflect the agency’s current thinking and either revise or finalize the documents.

In the review, CDER identified 23 draft guidance documents for withdrawal in the areas of CGMP compliance, development of antimicrobial drugs, abbreviated new drug applications (ANDAs), labeling of ANDAs, and more. Guidance documents to be withdrawn include but are not limited to:

  • “Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients”—issued April 1998
  • “Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment”—issued November 2003
  • “Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution”—issued May 2001.
  • “Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning on January 1, 2000”—issued December 1999.
  • “Labeling Over-the-Counter (OTC) Human Drug Products—Updating Labeling in ANDAs”—issued February 2001.
  • “Inhalation Drug Products Packaged in Semipermeable Container Closure Systems”—issued July 2002.

CDER has identified guidance documents in the following topics and are developing a plan for revision or finalization:

  • Biopharmaceutics
  • Chemistry, manufacturing, and controls
  • Clinical pharmacology
  • Combination products
  • CGMP compliance
  • Development of antimicrobial drugs
  • Drug advertisements
  • Drug safety
  • Electronic submissions
  • Labeling
  • OTC products
  • Pharmacology and toxicology
  • Procedural guidance
  • Radiopharmaceuticals.

More information on the withdrawal, revision, and finalization of these guidance documents can be found on CDER’s website.

Source: Federal Register

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