FDA, i.e., Food and Drug Administration, the world’s largest regulator of pharmaceutical product market, assumes a large number of management functions, including pharmaceutical product review, inspection, evaluation and supervision, etc. Simultaneously with implementing federal regulations of the U.S., to make its own regulation work effective and flexible, FDA also drafts and issues lots of technical guidances for the reference of pharmaceutical industry practitioners. Those guidances have no legal effect, but show FDA’s perspectives and expectations on relevant issues, therefore, they have been attracting the attention of the pharmaceutical industry.
FDA issues information on drafting, revision and invalidation of relevant technical guidances at the beginning of every year; such information shows the work contents of FDA in the year, and is one of the data based on which the industry can study the U.S. pharmaceutical product regulation trend. I would like to introduce the latest progress of relevant technical guidances of FDA in 2017 for Chinese pharmaceutical industry practitioners according to the 2017 technical guidance work document recently issued by FDA.
The Guidance Agenda: New & Revised Draft guidances CDER is Planning to Publish During Calendar Year 2017, recently issued by FDA, comprehensively introduces the guidance documents to be revised and newly published by the Center for Drug Evaluation and Research (CDER) of FDA in 2017.
Part I: Overall Introduction to 2017 Guidance Documents
The following table contains the overall situation of guidances that the CDER of FDA is planning to revise and newly publish in 2017, which are distinguished by different topics.
|
Technical topic |
Number of guidance |
|
Pharmaceutical Product Advertising |
1 |
|
Biopharmaceutics |
3 |
|
Biosimilarity |
2 |
|
Clinical/Antimicrobial |
1 |
|
Clinical/Medical |
11 |
|
Clinical Pharmacology |
8 |
|
Clinical/Statistical |
3 |
|
Drug Safety |
3 |
|
Electronic Submissions |
4 |
|
Generics |
13 |
|
Pharmaceutical Product Labeling |
6 |
|
Pharmaceutical Quality/CMC |
11 |
|
Pharmaceutical Quality/GMP |
fiercepharma
May 6, 2019
biospectrumasia
February 28, 2017
biospectrumasia
February 28, 2017
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