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
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.


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..

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2009

Training CD / USB Drive

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CD/USB and Ref. material will be shipped within 15 business days

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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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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