FDA CDER released a list of (125) New & Revised Good Guidance Practices planned for 2017

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In early January, the FDA Center for Drug Evaluation and Research (CDER) released a new list of 125 new & Revised Guidances planned for 2017, divided into 16 categories.

For comparison, the 2016 list highlighted a total of 102 guidances within 15 categories. The new category this year is “User Fees” with 2 planned Guidances. Therapeutic items & areas of special interest include:

Paediatric

  • Paediatric Oncology Product Development; Revised Draft
  • Measuring Treatment Benefit in Paediatric Populations: Use of Clinical Outcome Assessments
  • Paediatric Drug Development Under the Paediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations; Revised Draft

Rare Diseases

  • Guidance for Clinical Investigators and Sponsors Natural History Studies for Rare Disease Drug Development (was in 2016 planned list)
  • Rare Diseases: Drug Development Safety Data Considerations

Pregnancy

  • Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
  • Pregnancy, Prevention and Planning: Recommendations for Pregnancy Testing and Contraception for Drugs with Teratogenic Potential
  • Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labelling; Revised Draft

Safety

  • Post-marketing Safety Reporting for Human Drugs and Biological Products Including Vaccines, Revised Draft

CMC changes

  • Drug Products, Including Biological Products, That Contain Nanomaterials

Procedural amendments

  • Civil Monetary Penalties for Failure to Meet Accelerated Post marketing Requirements
  • Identifying Trading Partners Under the Drug Supply Chain Security Act
  • Public Disclosure of FDA-Sponsored Studies

and last, but not least

  • Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. This could be the major document generated this year by CDER. It should be remembered that FDA worked 10 years ago on a revision of Part 11 that was never released, so this Q&A is very much expected.

Note: None of the 2016 planned “Clinical/Statistical” Guidances (1 revised draft & 2 new guidances) were released last year. Although the 2017 planned list is identical to the 2016 one, the interesting one named “Multiple Endpoints in Clinical Trials” was released on 12th January 2017.

For more details please refer to the source material which can be located at:
www.fda.gov/downloads/Drugs/GuidanceComplian…

Author

Clintec International

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