CDER SBIA Update: New Guidance Documents and the Clinical Investigator Training Course

New Guidance Documents and the Clinical Investigator Training Course

1. Draft Guidances describing GDUFA performance metrics and associated webinars

FDA published notices in the Federal Register announcing the availability of two draft guidances for industry:

• Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA, and
• Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA

These draft guidances are intended to assist applicants preparing to submit amendments to ANDAs, prior approval supplements, and amendments to prior approval supplements under the Federal Food, Drug, and Cosmetic Act, by explaining how the GDUFA performance metrics apply to these submissions.

Pre-recorded webinars explaining these guidances are available at:

• Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA 
  • Adobe Connect Link: https://collaboration.fda.gov/p98ulfi2wfd/
  • Download Presentation Slides: Prior Approval Supplements Under GDUFA (PDF - 353KB)
• Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA
  • Adobe Connect Link: https://collaboration.fda.gov/p2ehqu6hu81/
  • Download Presentation Slides: Amendments and Easily Correctable Deficiencies Under GDUFA (PDF - 529KB)

Submit electronic comments on the draft guidances to www.regulations.gov.

 

2. Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications

This draft guidance outlines Electronic Common Technical Document (eCTD) specification requirements for certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) and is being issued for public comment. This draft guidance revises and replaces a previous draft guidance entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” that was issued in January 2013 (2013 draft guidance on eCTD Specifications). When finalized, this revised draft guidance will supersede the guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” that was issued in June 2008.

Federal Register Notice

3. Clinical Investigator Training Course

FDA’s Center for Drug Evaluation and Research/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide clinical investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants. Senior FDA staff will communicate directly with clinical investigators on issues of greatest importance for successful clinical research.

Date and Time: The training course will be held on November 4 and 5, 2014, from 8 a.m. to 5 p.m., and on November 6, 2014, from 8 a.m. to 3:30 p.m.

Location: The course will be held at the Holiday Inn College Park, 10000 Baltimore Ave., College Park, MD 20740.

Please find details in the 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

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