FDA Unveils Plan for CDER Draft Guidance in 2018
Posted 19 January 2018 | By
The plan for 2018 draft guidance documents from the US Food and Drug Administration (FDA) includes more than 10 in three top categories, including FDA procedures, pharmaceutical quality/chemistry, manufacturing and controls (CMC) and clinical/medical.
Several notable draft guidance documents coming this year in the clinical/medical category include: "Early Alzheimer’s Disease: Developing Drugs for Treatment," "Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment," and "Streamlined Submission Process to Determine Whether an Investigational In Vitro Companion Diagnostic in an Oncology Trial is Significant Risk."
In the quality/CMC category, FDA lists: "In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products," "Drug Master Files; Revised Draft" and "Use of Liquids and/or Soft-Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments."
And in the procedural category, FDA said it’s planning guidance on "Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers," which companies sought revisions on as some said in comments on a March 2016 draft that the document could have a chilling effect on biosimilar development.
The list also features guidance on "Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements," "Three-Year Exclusivity Determinations for Drug Products," and a revision to a draft on 2017’s list: "Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft."
Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018