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Filing a 505(b)(2) Application

 
  January 14, 2015  
     
 
CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
January 21 2015 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This online training is designed for product development professionals, legal staff, Office of Compliance, regulatory staff. In addition, any pharmaceutical professional who needs to understand how the 505(b)(2) and 505(J) applications differ will benefit greatly from this training.

Course Description
This course will be available On Demand: January 22, 2015

Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), no person may introduce into interstate commerce a ™ drug unless that drug product is subject to an approved New Drug Application. (21 U.S.C. § 33 l (d).)

The 505(b)(2) application is different in that one can rely on information from prior approvals, but it is not limited in the application being identical, i.e., an ANDA. The application normally requires a meeting with the New Drug Review Division and negotiation over the design, type, size, and complexity of the cclinical data. The application is in line with an ANDA as to patent certification, but is different from an ANDA application in that it allows some potential market protection and the creation of a distinctive product.

This 90-minute accredited online training will address these differences and describe appropriate actions to take when filing a 505(b)(2).
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Gary L. Yingling, Esq., Senior Attorney , Morgan, Lewis & Bockius

Gary Yingling is a senior attorney in Morgan Lewis’s FDA Practice in Washington, DC. He focuses his practice on issues involving the U.S. Food and Drug Administration and has also represented clients in matters involving the Drug Enforcement Administration, the Federal Trade Commission, and various states. His clients have included corporations, partnerships and individuals in matters involving pre-IND, IND and end of Phase II meetings, NDA submissions, ANDA applications, paragraph IV filings, REMS, OTC Monographs, labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. He is a co-editor of Good Clinical Practice which focuses on FDA-regulated clinical trials. He has also counseled on FDA pre-approval manufacturing and clinical site inspections, assisted with 483 responses and been involved in all aspects of drug regulation.

Mr. Yingling earned his J.D. from Emory University School of Law in 1968. Prior to attending law school, he practiced community pharmacy and is a registered pharmacist in Maryland and D.C. He earned his M.S. from Purdue University in 1966 and his B.S. from University of North Carolina in 1962. He served in the FDA Office of General Counsel for a number of years and received FDA’s Award of Merit for his work on the OTC Review.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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