FDA Unveils Plan for CDER Draft Guidance in 2018

The plan for 2018 draft guidance documents from the US Food and Drug Administration (FDA) includes more than 10 in three top categories, including FDA procedures, pharmaceutical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Several notable draft guidance documents coming this year in the clinical/medical category include: "Early Alzheimer’s Disease: Developing Drugs for Treatment," "Amyotrophic Lateral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