CDER SBIA Update: CDER Vacancy Announcement and New Guidance Documents

CDER Vacancy Announcement and New Guidance Documents

1. Vacancy Announcement: Director, Office of Pharmaceutical Quality

CDER has posted a vacancy announcement for the Director of the Office of Pharmaceutical Quality (OPQ). This office oversees and coordinates the overall regulation of pharmaceutical quality with CDER, including submission review, assessment, and surveillance of the quality of marketed pharmaceutical products; the design and execution of all OPQ office programs; and the coordination of partnerships between offices, centers and agencies required to execute assigned program responsibilities.

Interested candidates should submit their resume or curriculum vitae including any experience, training, and skills which have prepared you for this assignment; SF-50 and a copy of your transcript and any publications toCDERExecutiveRecruitment@fda.hhs.gov.

CDER also has additional open executive level positions that encompass a variety of disciplines.

2. Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling

This guidance explains FDA's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. This guidance also makes recommendations about how those studies should be performed and evaluated, and discusses how to describe those studies and their implications in product labeling. It is intended to assist sponsors who wish to develop opioid drug products with potentially abuse-deterrent properties and is not intended to apply to products that are not opioids or opioid products that do not have the potential for abuse.

Federal Register Notice

Guidance Document

3. Guidance for Industry; Critical Path Innovation Meetings

This guidance describes a Critical Path Innovation Meeting (CPIM), a means by which CDER and investigators from industry, academia, government, and patient advocacy groups can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. The discussions and background information submitted through the CPIM are nonbinding on both FDA and CPIM requesters.

Federal Register Notice

Guidance Document

4. Draft Guidance for Industry; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products

This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (“products”). This draft guidance revises the guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants” published May 19, 2009.

Federal Register Notice

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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

Please take our CDER SBIA survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation