The Center for Drug Evaluation and Research (CDER) has released a list of more than 50 new and revised draft guidance documents that it plans to publish in 2013.
On the GMP side, CDER’s compliance office is listed as the sponsor for the following guidances due to be released: ● Quality Systems Approach to Pharmaceutical cGMP Regulation ● Uniformity of In-Process Mixtures ● Control of Highly Potent Compounds, and ● Submission of Field Alert Reports and Biological Product Deviation Reports.
Other GMP-related documents in the works will address two aspects of drug contract manufacturing arrangements: quality agreements, and Pre-Launch Activities Importation Request (PLAIR).
Two guidance documents are planned regarding biosimilars: Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products, and Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.
On the CMC side, guidance documents being proposed include: ● CMC Postapproval Manufacturing Changes Reportable in Annual Reports for Specified Biological Products, and ● Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information.
For the complete list of documents, click here.[/membership]