DSCSA Pilot Program/ Patient Perspectives on Clinical Trials/ New Guidance Documents

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DSCSA Pilot Program/ Patient Perspectives on Clinical Trials/ New Guidance Documents

1. Drug Supply Chain Security Act (DSCSA) Pilot Project Program

The FDA is announcing the start of the Pilot Project Program Under the Drug Supply Chain Security Act (DSCSA Pilot Project Program). The DSCSA Pilot Project Program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the United States. Under this program, FDA will work with stakeholders to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Participation in the DSCSA Pilot Project Program is voluntary and will be open to pharmaceutical distribution supply chain members to apply to the program. FDA will ensure that participation reflects the diversity of the supply chain, including large and small entities from all industry sectors. This notice establishes the DSCSA Pilot Project Program and includes instructions for submitting a request to participate and expectations for program participants.

FDA will be accepting applications for participation in the DSCSA Pilot Project Program beginning February 8, 2019 and continuing through March 11, 2019. The duration of the DSCSA Pilot Project Program will depend on the pilot project(s) accepted into the program and when the projects are completed.

For more information, please visit DSCSA and read the Federal Register Notice.

2.  Public Workshop: Enhancing the Incorporation of Patient Perspectives on Clinical Trials

This workshop will be held on March 18, 2019, and will be convened by the Clinical Trials Transformation Initiative (CTTI). The topic to be discussed is stakeholders' (including patients, caregivers, industry, academic researchers, and expert practitioners) perspectives on challenges and barriers to patients participating in clinical trials and best practices and considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial follow-up. The workshop will result in a publicly available report from CTTI on proceedings and recommendations from discussions at the workshop. Submit either electronic or written comments on this public workshop by May 20, 2019.

Find details in the Federal Register Notice.

3. Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C - Guidance for Industry and FDA Staff

The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C – Recalls (Including Product Corrections) –Guidance on Policy, Procedures, and Industry Responsibilities. The guidance also discusses what information should be included in a public warning, as well as the parties responsible for issuing it. It represents FDA’s current thinking on public warning and notification of recalls under 21 CFR Part 7.

4. Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway- Guidance for Industry 

This guidance is intended to assist applicants in developing the INDICATIONS AND USAGE section of labeling for human prescription drug and biological products that are approved under the accelerated approval regulatory pathway. 

5. Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment – Guidance for Industry

This guidance reflects the Agency’s current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder (OUD). It focuses on the development of depot buprenorphine products for which submission of a new drug application (NDA) through the pathway described in section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may be appropriate.

6. Eosinophilic Esophagitis: Developing Drugs for Treatment - Guidance for Industry  

The purpose of this guidance is to assist sponsors in the clinical development of drugs and therapeutic biologics for the treatment of eosinophilic esophagitis (EoE). Specifically, this guidance addresses the FDA’s current recommendations regarding clinical trials for EoE drugs and the necessary attributes of patients for enrollment, efficacy assessments, safety assessments, and pediatric considerations.

7. Principles of Premarket Pathways for Combination Products – Guidance for Industry and FDA Staff

This guidance presents the current thinking of FDA on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. This guidance offers general, high-level information relevant to combination products. The Agency has published guidance on premarket review issues relevant to specific categories of combination products and will continue to use such guidance as needed to provide more detailed information on specific premarket considerations and specific types of combination products.