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