CDER SBIA Update

New Guidance Documents and Meetings

1. Guidance for Industry - Analytical Procedures and Methods Validation for Drugs and Biologics

This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on “Analytical Procedures and Methods Validation” and the 1987 FDA guidance for industry on “Submitting Samples and Analytical Data for Methods Validation.”

Federal Register Notice

Guidance Document

2. Draft Guidance for Industry - Gastroparesis: Clinical Evaluation of Drugs for Treatment

This draft guidance is intended to provide FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis.

Federal Register Notice

Guidance Document

3. Public Meeting / Request for Comments - Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access

The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, the scientific community, the pharmaceutical industry, public health agencies, patients, patient advocates, health care system administrators, prescribers, dispensers, hospitals, infusion centers, health informatics experts, third-party payers, distributors, and the general public concerning the impact of REMS on the health care delivery system, including the impact on patients and health care providers. The discussion will focus on strategies for characterizing and evaluating the impact of REMS on the health care delivery system and on patient access to drugs subject to REMS.

The meeting will be held on October 5, 2015, from 8 a.m. to 5 p.m. and October 6, 2015, from 8 a.m. to 1 p.m. at the FDA White Oak Campus in Silver Spring, MD 20993-0002.

Federal Register Notice

4. Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate

FDA is issuing this notice to request that public stakeholders—including patient and consumer advocacy groups, health care professionals, and scientific and academic experts—notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.

Submit notification of intention to participate in these series of meetings to PDUFAReauthorization@fda.hhs.gov by August 28, 2015. Stakeholder meetings will be held monthly at the FDA campus in Silver Spring, MD. It is anticipated that they will commence in September or October 2015.

Federal Register Notice

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

• Email: CDERSBIA@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia