News about GMP/cGMP


CDER List for 2017 Guidance Documents

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to publish in 2017. A total of 102 planned guidance documents have been set out.


The guidances are categorized in 16 different themes.

Three documents are listed under the category „Biosimilarity“:

  • Considerations in Demonstrating Interchangeability With a Reference Product
  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Under the category „Pharmaceutical Quality/Manufacturing Standards (CGMP)“ can be found 4documents:

  • Current Good Manufacturing Practice for Medical Gases; Revised Draft
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft (already listed 2016)
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities (already listed since 2015)

The related category „Pharmaceutical Quality/CMC” lists 11 additional guidances:

  • CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports
  • Container Closure Systems for Packaging Human Drugs and Biologics; Revised Draft
  • Drug Master Files; Revised Draft
  • Drug Products, Including Biological Products, That Contain Nanomaterials
  • GDUFA II Priority ANDA Pre-Submission Communications
  • Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
  • In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
  • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft
  • Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software
  • Use of the FDA Inactive Ingredient Software (IID)
  • Visual Inspection of Injectable Drug Products

If you are interested to take a look at the full list of guidances, please click here.


FDA: CDER list