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FDA has released a list of more than 50 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:
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.