New Drug Applications (NDA’s), Investigational New Drugs (IND’s) and the Drug cGMP’s

The regulation and control of new drugs for sale in the US is based on the NDA and the IND development and clinical process. Manufacturing of drugs must be under the Drug cGMPs, 21 CFR 210/211. For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization.

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.

Why You Should Attend:

This webinar will discuss current US Federal law on NDAs and INDs and associated requirements for getting a new drug through the US FDA review process and to market in the USA. US law and the FDA require that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. Once the drug product receives FDA approval for sale in the US, it must be manufactured under the Pharmaceutical cGMPs, 21 CFR 210 and 211. The webinar will also discuss the key requirements for the pharmaceutical cGMPs in the control. manufacture, and testing / OQ /QA of drug products destined for sale in the USA, no matter where manufactured.

Areas Covered in the Session :

  • Drugs and the US FDA
  • The NDA process
  • The IND process
  • Gearing up for production – The Drug cGMPs
  • Key areas of concern
  • Post-market requirements

Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Pharma product development teams
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Marketing Departments
  • Documentation Departments
  • Everyone tasked with drug product development, manufacturing, process / product / data analysis, regulatory submission responsibilities

FDB3786

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance