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What's New from Process Development Forum
FDA Releases List of Planned Guidance Documents 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. 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.
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GE Healthcare Offers Free Resources for Process Development Applications and Techniques
GE Healthcare Life Sciences offers handbooks covering a wide range of techniques and applications including protein purification, antibody purification, chromatography, electrophoresis, cell culture and many other areas.

Whether you’re a beginner or an expert, the handbooks are a great reference for practical tips and in-depth information about common methodologies used in the lab. Continue Reading

Questions for 2013
Like what you read? Want to see more of something in particular? Let us know what topics are on your mind and what you'd like to see more of in 2013.