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News|Articles|February 5, 2013
FDA Lists Guidance Documents Planned for 2013
Author(s)Amy Ritter, PhD
FDA has released a list of more than 50 guidance documents planned for 2013.
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FDA has released a
- 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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