FDA Lists Guidance Documents Planned for 2013 - - BioPharm International

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FDA Lists Guidance Documents Planned for 2013



FDA has released a list of more than 50 guidance documents planned for 2013.  The list reflects guidance documents currently under development as of the date of the posting, Jan. 31, 2013. Planned documents relevant to cGMP and compliance include: 

  • Quality Systems Approach to Pharmaceutical cGMP Regulation (OMPQ)
  • Uniformity of In-Process Mixtures (OMPQ)
  • Control of Highly Potent Compounds (OMPQ)
  • Contract Manufacturing Arrangements for Drugs: Quality Agreements
  • Submission of Field Alert Reports and Biological Product Deviation Reports (OMPQ)
  • Pre-Launch Activities Importation Request (PLAIR)

With regards to biosimilars, the agency plans a guidance on Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products, as well as one titled Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.

Other guidance documents in the planning stage include Securing the Drug Supply Chain—Standards for Tracking and Tracing Prescription Drug Packages, and a guidance on compounded medications titled Pharmacy Compounding of Human Drugs Under Section 503A of the Federal Food, Drug, and Cosmetic Act.

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