The regulation and control of new drugs for sale in the US is based on the NDA and the IND development and clinical process. A key section of these submissions is the CMC, Chemistry, Manufacturing, and Controls.
This webinar will discuss current US Federal law on NDAs and INDs, CMC, and other 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. The CMC section of these applications assures the drug retains its reviewed/approved formulation throughout its life. Also, 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. The CTD is the preferred format for submission, increasingly worldwide. 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.
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 (or ANDA) 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. A critical component of these submissions is the CMC - Chemistry, Manufacturing, and Controls.
The CMC section assures the reviewer that the approved drug will maintain its approved consistencd The data gathered during the animal studies and human clinical trials of an Investigational, stability, formulation, et al, throughout its production lifecycle. New Drug (IND)also becomes 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. The CTD, Common Technical Document, has become the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the US FDA.
John E. Lincoln is the Principal of J. E. Lincoln and Associates, a consulting company with over 41 years of experience in U.S. FDA-regulated industries, 27 of which as head of his own consulting company. John has worked with companies from start-ups 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, FDA responses, new/changed product 510(k)s, process/product/equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He's held Manufacturing Engineering, QA, QAE, and Regulatory Affairs positions at the Director and VP (R&D) levels. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, including 5 chapters in the RAPs validation textbook, and conducted workshops and webinars worldwide on regulatory issues. John is a graduate of UCLA.