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Course / Course Details

Drug Regulatory System In Us

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 1 students
  • 3 Hours
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.


Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course covers History of FDA and Related Regulatory Agencies, FDA & CDER – Organization and responsibilities, Types of Drug applications in US [IND, NDA, ANDA, 505 (b)(2)],Investigational New Drug Application: INDA , New Drug Application: NDA, Generic Drug Submissions, ANDA submission in detail, Bioequivalence Recommendation for Specific Products, Establishment registration, drug registration and National Drug Code Directory (NDC), Changes to an approved ANDA and annual reporting, Over-the-Counter Drug Products, Regulation of OTC Drugs

Course Curriculum

  • 2 chapters
  • 4 lectures
  • 0 quizzes
  • 3 Hours total length
Toggle all chapters
1 About Us
15 Min

1 Drug Regulation in US
15 Min

2 FDA Drug Approval Video
1 Min

3 Labelling requirement
1 Min

Instructor

Rajashri Ojha

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11 Students
141 Courses

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  • Duration 3 Hours

  • Lectures 4 lessons

  • Enrolled 1 students

  • Category: Pharmaceutical

  • 0 Quizzes

  • Language: English

  • Skill Level Short Courses

  • Certificate of Completion

  • 7 Days Access

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