ComplianceOnline

The New FDA Prescription drug labeling requirements: Learn to create Prescription Drug Labeling in compliance with the rule and understand the essential elements

Instructor: R. Wayne Frost
Product ID: 701190
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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This Drug Labeling training will provide valuable assistance to those individuals who will be involved in the preparation of prescription drug labeling for new NDA submissions.

Description

The Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, January 24, 2006. Effective June 30, 2006.This final rule amends part 201 (21CFR part 201) of FDA regulations by revising the requirements for the content and format of labeling for prescription drug products. The final rule provides that new and more recently approved products comply with revised content and format requirements (201.56(d)), to include drug products with an NDA, BLA, or efficacy supplement that: (1) Was approved between June 30, 2001, and June 30, 2006; (2) is pending on June 30, 2006;or (3) is submitted anytime on or after June 30, 2006 (201.56(b)(1))The final rule also requires that any FDA approved patient labeling either: (1)Accompany the prescription drug labeling or (2) be reprinted at the end of such labeling (201.57(c)(18) and 201.80(f)(2)). For the purposes of this document, the term ‘‘FDA-approved patient labeling’’ will be used to refer to any approved printed patient information or Medication Guide..

Areas Covered in the seminar:

  • Understand the history of the drug labeling initiative.
  • Become familiar with the required elements of the new labeling required sections.
  • Describe the staged implementation schedule for the revised prescription drug labeling.
  • Describe the major content and format changes to prescription drug labeling and the rationale for the changes.
  • Learn how to put together prescription drug labeling which complies with the "new" requirements.

Who will benefit: This webinar will provide valuable assistance to those individuals who will be involved in the preparation of prescription drug labeling for new NDA submissions or for those needing to change the format of their current PI's to conform to the new prescription drug labeling requirements.

  • Regulatory Affairs
  • Clinical Research
  • Safety and Medical Affairs
  • Biopharmaceutics
  • Marketing and Sales

Instructor Profile:
R. Wayne Frost, Pharm.D., JD is the President of Frost Biopharmaceutical Consulting, a consulting firm focused on assisting companies in bringing their drug products to market. We provide services in the areas of overall drug development, regulatory strategy/liaison, clinical development, regulatory affairs submissions including IND's NDA's and REMS, DDMAC, labeling and regulatory compliance. Dr Frost has over 20 years experience in the industry having held positions in Pharmacokinetics, Professional Services/Medical Affairs, Clinical Research, Regulatory Affairs and Quality Assurance/Compliance. He has worked for large Pharma and Biotech as well as small biotechnology companies and is experienced in all aspects of drug development. He has gained approvals for new products in many therapeutic areas in US, Canada, and EU.

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